Multi-use scope

ABSTRACT

An endoscope/triplescope (combined gastroscope, bronchoscope, laryngoscope) device and/or system includes an endoscope having an outer diameter of less than about 4.0 millimeters, in particular less than about 3.5 millimeters, that allows high resolution viewing having a distal element including an optical element that allows four way tip deflection. Further, the device may include a scope stiffening apparatus to minimize the endoscopes flexibility when needed, a foot and hand activation to allow air/water insufflation and image/video capture, a light source, an interior conduit having a diameter greater than about 2 mm, one or more sensor arrays, audio elements for transcription of report, sensors to measure body cavity findings.

CROSS-REFERENCE TO RELATED APPLICATIONS Related Applications andIncorporation by Reference

This application is a continuation-in-part application of internationalpatent application Serial No. PCT/US16/39352 filed Jun. 24, 2016, whichpublished as PCT Publication No. WO 2016/210322 on Dec. 29, 2016, whichclaims benefit of U.S. Provisional Application No. 62/184,077, filed onJun. 24, 2015. This application is also a continuation-in-part of U.S.application Ser. No. 15/850,939 filed Dec. 21, 2017.

The foregoing applications, and all documents cited therein or duringtheir prosecution (“appin cited documents”) and all documents cited orreferenced in the appin cited documents, and all documents cited orreferenced herein (“herein cited documents”), and all documents cited orreferenced in herein cited documents, together with any manufacturer'sinstructions, descriptions, product specifications, and product sheetsfor any products mentioned herein or in any document incorporated byreference herein, are hereby incorporated herein by reference, and maybe employed in the practice of the invention. More specifically, allreferenced documents are incorporated by reference to the same extent asif each individual document was specifically and individually indicatedto be incorporated by reference.

FIELD OF THE INVENTION

This invention relates to a device and its uses for evaluating multipleconditions. A device as described herein may be capable of being usedfor multiple end uses, including for example, an endoscope, such as anasal endoscope, a triple endoscope, a bronchoscope, a laryngoscope, agastroscope, an aerodigestive scope, and/or an endoscopic device used tovisualize any body cavity to which it would fit.

As described herein devices may encompass multiple functionalities whilemaintaining specific sizes to allow for ease of use and/or patientcomfort. In some instances, for example, in veterinary medicine and/ormedicine, such as in pediatrics or small adults, it may be necessary tocreate devices having smaller diameters while maintaining thefunctionality. For example, the evaluation and treatment of eosinophilicesophagitis, esophagitis, gastritis, celiac disease, gastric infection,gastric ulcer, duodenal ulcer and aerodigestive conditions, in children,small adults, and in outpatient or emergent settings where agastrointestical procedural suite or operating room are not availablemay be of particular interest. More specifically, some embodiments ofthis invention may relate to pediatric or adult nasal endoscopes.

BACKGROUND OF THE INVENTION

Eosinophilic esophagitis (EoE) is an increasingly common chronicinflammatory disease that affects children and adults with an estimatedincidence of 1/10,000 in the United States. [Dellon E S, Gonsalves N,Hirano I, et al. ACG clinical guideline: Evidenced based approach to thediagnosis and management of esophageal eosinophilia and eosinophilicesophagitis (EoE). Am J Gastroenterol 2013; 108:679-92; quiz 693]Because of its potential to progress to esophageal stricture and thefact that symptoms do not always correlate with degree of eosinophilia,much attention has been paid to repeated assessment of the esophagealmucosa to insure mucosal healing following treatment. In contrast, therisks, cost and time commitment associated with traditional sedatedesophagogastroduodenoscopy (EGD) can be significant and have raisedconcerns for providers and parents alike. [Gleich S J, Flick R, Hu D, etal. Neurodevelopment of children exposed to anesthesia: Design of theMayo Anesthesia Safety in Kids (MASK) study. Contemp Clin Trials 2014;41C:45-54] These dilemmas challenge the gastroenterologist tocontemplate if EGD use in EoE is meeting the goal of Berwick's tripleaim in health care to provide effective treatment, low cost care, and anoptimal and safe healthcare experience. [Berwick D M, Nolan T W,Whittington J. The triple aim: care, health, and cost. Health Aff(Millwood) 2008; 27:759-69] Should EGD with biopsy be performed aftereach therapeutic change regardless of symptomatology, should EGD bereserved for patients who are not clinically responding to treatment, orshould EGD not be performed again if patients are feeling well?

To address these questions, alternative methods are urgently needed tomeasure esophageal inflammation. While esophagoscopy with biopsiesremains the gold standard technique for assessing mucosal inflammation,other technologies such as the Cytosponge, esophageal string test andconfocal tethered endomicroscopy have emerged as potential alternatives.[Furuta G T, Kagalwalla A F, Lee J J, et al. The oesophageal stringtest: a novel, minimally invasive method measures mucosal inflammationin eosinophilic oesophagitis. Gut 2013; 62:1395-405; Tabatabaei N, KangD, Wu T, et al. Tethered confocal endomicroscopy capsule for diagnosisand monitoring of eosinophilic esophagitis. Biomed Opt Express 2013;5:197-207; Katzka D A, Geno D M, Ravi A, et al. Accuracy, safety, andtolerability of tissue collection by Cytosponge vs endoscopy forevaluation of eosinophilic esophagitis. Clin Gastroenterol Hepatol 2015;13:77-83 e2.] To date, these tools, while less invasive, are stillavailable only in research settings. [Dellon E S, Gonsalves N, Hirano I,et al. Am J Gastroenterol 2013; 108:679-92; quiz 693; Furuta G T,Kagalwalla A F, Lee J J, et al., Gut 2013; 62:1395-405]

Recent work has led to the development of transnasalendoscopy/esophagoscopy (TNE) to assess the esophageal mucosa in adults.[Birkner B, Fritz N, Schatke W, et al. A prospective randomizedcomparison of unsedated ultrathin versus standardesophagogastroduodenoscopy in routine outpatient gastroenterologypractice: does it work better through the nose? Endoscopy 2003;35:647-51; Dumortier J, Josso C, Roman S, et al. Prospective evaluationof a new ultrathin one-plane bending videoendoscope for transnasal EGD:a comparative study on performance and tolerance. Gastrointest Endosc2007; 66:13-9; Dumortier J, Ponchon T, Scoazec J Y, et al. Prospectiveevaluation of transnasal esophagogastroduodenoscopy: feasibility andstudy on performance and tolerance. Gastrointest Endosc 1999; 49:285-91;Hu C T. Gauze pledgetting versus endoscopic-guided aerosolized spray fornasal anesthesia before transnasal EGD: a prospective, randomized study.Gastrointest Endosc 2010; 71:11-20; Mokhashi M S, Wildi S M, Glenn T F,et al. A prospective, blinded study of diagnostic esophagoscopy with asuperthin, stand-alone, battery-powered esophagoscope. Am JGastroenterol 2003; 98:2383-9; Mulcahy H E, Riches A, Kiely M, et al. Aprospective controlled trial of an ultrathin versus a conventionalendoscope in unsedated upper gastrointestinal endoscopy. Endoscopy 2001;33:311-6; Yagi J, Adachi K, Arima N, et al. A prospective randomizedcomparative study on the safety and tolerability of transnasalesophagogastroduodenoscopy. Endoscopy 2005; 37:1226-31] In contrast totraditional EGDs, TNE offers advantages including that it can beperformed in an outpatient clinic room, requires no anesthesia orsedation, uses an adult transnasal gastroscope that is tolerated byadults and procures samples adequate for assessment of Barrett'sEsophagus. [Shariff M K, Bird-Lieberman E L, O'Donovan M, et al.Randomized crossover study comparing efficacy of transnasal endoscopywith that of standard endoscopy to detect Barrett's esophagus.Gastrointest Endosc 2012; 75:954-61; Saeian K, Staff D M, VasilopoulosS, et al. Unsedated transnasal endoscopy accurately detects Barrett'smetaplasia and dysplasia. Gastrointest Endosc 2002; 56:472-8] However,the endoscopes used in the adult procedures are not appropriate for usein pediatric setting. Adult endoscopes and nasal endoscopes have a largebulky head, will not fit in many pediatric size or small adult nasalpassages, are hard to control by individuals with small hands, do nothave optional stiffening capability for improved maneuverability, do nothave foot controls or a full array of hand button controls, are notconnected to or allow voice dictation of reports, are not able to beused in pediatrics or small adults, and are unable to be used forbronchoscopy. Accordingly, what is needed is a device and associatedmethodology that can be used to adapt THE to assess the esophagealmucosa, gastric, and duodenal, tracheal, and bronchial mucosa inchildren and small adults in both a sedated and unsedated manner with aa full array of steering and a channel large enough to enable fullevaluation of the above tissues. The present invention provides toolsand techniques to meet this important need.

Citation or identification of any document in this application is not anadmission that such document is available as prior art to the presentinvention.

SUMMARY OF THE INVENTION

For example, there is a long-standing but heretofore unfulfilled needfor is now met by a new, useful, and nonobvious pediatric nasalendoscope, triplescope, gastroscope, aerodigestive, bronchoscope. Anembodiment of the invention includes a miniaturized 3-4 mm flexible,fiber optic endoscope approximately 1-1.2 meter in length that allowshigh resolution, high definition, and clear optics of the nasal mucosa,pharynx and upper gastrointestinal tract with the small head of apediatric bronchoscope that allows four way tip deflection to allow useby individuals with small hand sizes, an optional foot pedal to allowair/water insufflation for ease of use, a bright light source, anoptional scope stiffening apparatus that will allow utilization inaerodigestive medicine (combined ENT-laryngoscopy, Pulmonary(bronchoscopy), and Gastroenterology (EGD) Procedures), an optionalsensor array to allow the scope to sense in collaboration with itsreporting systems distance from insertion, an optional sensor array tomap and measure objects in the body cavity, a microphone to allowdictation into a reporting system and/or voice activation, and a 1.3-2.2mm biopsy channel to assure utilization of currently availableendoscopic tools.

An endoscopic device may include a control element having ports,interface elements; and indicators. The control element may be coupledto an elongated element that is also coupled to a distal element. Theelongated element may have a cross-sectional outer diameter of less thanabout 3.5 millimeter. Further, the elongated element may include aconduit, in particular, a non-collapsible conduit having a diameter in arange between about 1.0 to about 2.5 millimeters in diameter. The distalelement may include an illumination element, an optical element thatwill transmit images and/or video (via wires or wireless transmission)to an display (including video goggles) and a reporting system. Thereporting system may be voice activated and/or activated or controlledusing interface elements. The device of claim 1 wherein the diameter ofthe non-collapsible conduit is in a range between about 1.3 to about 2.2millimeter.

The control element is optionally removable in some embodiments.

At least one of the interface elements of the control element is afour-way or greater distal element control mechanism.

In some embodiments, a diameter of the non-collapsible conduit is in arange between about 1.3 to about 2.2 millimeter.

Optical elements for use in an embodiment have a field of view of atleast eighty-five degrees and a depth of view of at least 5 mm. In someinstances, the depth of view may exceed 100 mm.

In some embodiments, a sound interface in the device, and in particular,in the control element may be coupled to a computer system to allow foruse of voice commands. In particular, it may be possible to activate adictation module during use of the device, so that the notes can berecorded. Further, voice activation may be used to activate any numberof features of the device.

Sensors and/or elements may be configured to transmit data using wiredand/or wireless connection. Sensors may be configured to interact withsensors and/or markers positioned on, in, or near a patient during useto determine a position or condition of the patient. For example, adistance and location sensor may interfaces with a computer system tonote location and distance of a scope from the insertion point of thescope. A further sensor may measure a luminal diameter and surfacefeatures of a body cavity the scope is visualizing.

An endoscope system may include a removable control element havingports, interface elements, and indicators. Further, the endoscope mayinclude an elongated element coupled to a control element having across-sectional outer diameter of less than four millimeter andincluding a conduit or channel having a diameter of at least 1.3 mm notgreater than 2.2 mm. Further the a distal element includes anillumination element and an optical element. The system further includesa computer control unit having one or more device drivers. In addition,the system may include a computer and one or more display elements.

Audio elements such as microphones may be utilized to control functionsof the system, including for example, the functioning of sensors.Further, audio elements may be used to facilitate auto-reporting,voice-activated commands, dictation, recording, and/or populatingreports and/or databases. An interface element may be configured to senddata from at least one of the optical element, the audio element and thesensor array to a computer.

Accordingly, it is an object of the invention not to encompass withinthe invention any previously known product, process of making theproduct, or method of using the product such that Applicants reserve theright and hereby disclose a disclaimer of any previously known product,process, or method. It is further noted that the invention does notintend to encompass within the scope of the invention any product,process, or making of the product or method of using the product, whichdoes not meet the written description and enablement requirements of theUSPTO (35 U.S.C. § 112, first paragraph) or the EPO (Article 83 of theEPC), such that Applicants reserve the right and hereby disclose adisclaimer of any previously described product, process of making theproduct, or method of using the product. It may be advantageous in thepractice of the invention to be in compliance with Art. 53(c) EPC andRule 28(b) and (c) EPC. All rights to explicitly disclaim anyembodiments that are the subject of any granted patent(s) of applicantin the lineage of this application or in any other lineage or in anyprior filed application of any third party is explicitly reserved.Nothing herein is to be construed as a promise.

It is noted that in this disclosure and particularly in the claimsand/or paragraphs, terms such as “comprises”, “comprised”, “comprising”and the like can have the meaning attributed to it in U.S. patent law;e.g., they can mean “includes”, “included”, “including”, and the like;and that terms such as “consisting essentially of” and “consistsessentially of” have the meaning ascribed to them in U.S. patent law,e.g., they allow for elements not explicitly recited, but excludeelements that are found in the prior art or that affect a basic or novelcharacteristic of the invention.

These and other embodiments are disclosed or are obvious from andencompassed by, the following Detailed Description.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

The following detailed description, given by way of example, but notintended to limit the invention solely to the specific embodimentsdescribed, may best be understood in conjunction with the accompanyingdrawings.

FIG. 1 is an image showing a biopsy with active EoE using a standard 2.8mm EGD forceps. The surface area is 0.10 mm².

FIG. 2 is an image showing a biopsy from the same patient with activeEoE using THE 1.2 mm forceps. The surface area is 0.12 mm².

FIG. 3 is an image taken from a subject with active furrowing andeosinophilic exudates.

FIG. 4 is a drawing depicting an illustrative example of a pediatricnasal endoscope.

FIG. 5 is a drawing depicting an illustrative example of a pediatricnasal endoscope biopsy forceps.

FIG. 6 is a block diagram depicting a system that incorporates anendoscope.

FIG. 7A is an exploded view of an illustrative example of the distal andelongated elements of an endoscope.

FIG. 7B is an exploded view of an illustrative example of the distal andelongated elements of an endoscope.

FIG. 8 is a drawing depicting an end view of an illustrative example ofa distal element for an endoscope.

FIG. 9 is a drawing depicting a cross-sectional view of an illustrativeexample of a distal element for an endoscope.

FIG. 10 is a drawing depicting a perspective view of an illustrativeexample of a distal element for an endoscope.

FIG. 11 is a drawing depicting an end view of an illustrative example ofa distal element for an endoscope.

FIG. 12 is a drawing depicting a cross-sectional view of an illustrativeexample of a distal element for an endoscope.

FIG. 13 is a drawing depicting a perspective view of an illustrativeexample of a distal element for an endoscope.

FIG. 14 is a drawing depicting a top view of an illustrative example ofa distal element for an endoscope.

FIG. 15 is a drawing depicting an end view of an illustrative example ofa distal element for an endoscope.

FIG. 16 is a drawing depicting an end view of an illustrative example ofa distal element for an endoscope.

FIG. 17 is a drawing depicting a cross-sectional view of an illustrativeexample of a distal element for an endoscope.

FIG. 18 is a drawing depicting a perspective view of an illustrativeexample of a distal element for an endoscope.

FIG. 19 is a drawing depicting a top view of an illustrative example ofa distal element for an endoscope.

FIG. 20 is a drawing depicting an end view of an illustrative example ofa distal element for an endoscope.

FIG. 21 is a drawing depicting a cross-sectional view of an illustrativeexample of a distal element for an endoscope.

FIG. 22 is a drawing depicting a perspective view of an illustrativeexample of a distal element for an endoscope.

FIG. 23 is a drawing depicting a top view of an illustrative example ofa distal element for an endoscope.

FIG. 24 is a drawing depicting an end view of an illustrative example ofa distal element for an endoscope.

FIG. 25 is a drawing depicting a perspective view of an illustrativeexample of a distal element for an endoscope.

FIG. 26 is a drawing depicting a side view of an illustrative example ofa distal element for an endoscope.

FIG. 27 is a drawing depicting an end view of an illustrative example ofa distal element for an endoscope.

FIG. 28 is a drawing depicting a cross-sectional view of an illustrativeexample of a distal element for an endoscope.

FIG. 29 is a drawing depicting a perspective view of an illustrativeexample of a distal element for an endoscope.

FIG. 30 is a drawing depicting a top view of an illustrative example ofa distal element for an endoscope.

FIG. 31 is a drawing depicting an end view of an illustrative example ofan overmold for a distal element for an endoscope.

FIG. 32 is a drawing depicting an end view of an illustrative example ofan overmold for a distal element for an endoscope.

FIG. 33 is a drawing depicting an end view of an illustrative example ofan overmold for a distal element for an endoscope.

FIG. 34 is a drawing depicting a top perspective view of an illustrativeexample of a control element for an endoscope.

FIG. 35 is a drawing depicting a front perspective view of anillustrative example of a control element for an endoscope.

FIG. 36 is a drawing depicting a top perspective view of an illustrativeexample of a control element for an endoscope.

FIG. 37 is a drawing depicting a side perspective view of anillustrative example of a control element for an endoscope.

FIG. 38 is a drawing depicting a side perspective view of anillustrative example of a control element for an endoscope.

FIG. 39 is a block diagram depicting a system that incorporates anendoscope.

FIG. 40 is a block diagram depicting a system that incorporates anendoscope.

FIG. 41 is a screenshot of a setup display for the system.

FIG. 42 is a screenshot of a working display for the system.

DETAILED DESCRIPTION OF THE INVENTION

Scopes having various functionality are increasingly important. Thereare many different types of scopes used for different purposes and oftendiffering in size to accommodate the different elements required to meetthe needs of the various. In the marketplace, there is a need for scopeswhich can accommodate the requirements of these various uses whilemaintaining dimensions that allow for ease of use and comfort level ofpatients. In particular, there is a need for small diameter scopes thatare more easily accommodated by patients of varying size.

For example, there is a long-standing but heretofore unfulfilled needfor is now met by a new, useful, and nonobvious pediatric nasalendoscope, triplescope, gastroscope, aerodigestive, bronchoscope. Anembodiment of the invention includes a miniaturized 3-4 mm flexible,fiber optic endoscope approximately 1-1.2 meter in length that allowshigh resolution, high definition, and clear optics of the nasal mucosa,pharynx and upper gastrointestinal tract with the small head of apediatric bronchoscope that allows four way tip deflection to allow useby individuals with small hand sizes, an optional foot pedal to allowair/water insufflation for ease of use, a bright light source, anoptional scope stiffening apparatus that will allow utilization inaerodigestive medicine (combined ENT-laryngoscopy, Pulmonary(bronchoscopy), and Gastroenterology (EGD) Procedures), an optionalsensor array to allow the scope to sense in collaboration with itsreporting systems distance from insertion, an optional sensor array tomap and measure objects in the body cavity, a microphone to allowdictation into a reporting system and/or voice activation, and a 1.3-2.2mm biopsy channel to assure utilization of currently availableendoscopic tools.

An endoscopic device may include a control element having ports,interface elements; and indicators. The control element may be coupledto an elongated element that is also coupled to a distal element. Theelongated element may have a cross-sectional outer diameter of less thanabout 3.5 millimeter. Further, the elongated element may include aconduit, in particular, a non-collapsible conduit having a diameter in arange between about 1.0 to about 2.5 millimeters in diameter. The distalelement may include an illumination element, an optical element thatwill transmit images and/or video (via wires or wireless transmission)to an display (including video goggles) and a reporting system. Thereporting system may be voice activated and/or activated or controlledusing interface elements. The device of claim 1 wherein the diameter ofthe non-collapsible conduit is in a range between about 1.3 to about 2.2millimeter.

The control element is optionally removable in some embodiments.

At least one of the interface elements of the control element is afour-way or greater distal element control mechanism.

In some embodiments, a diameter of the non-collapsible conduit is in arange between about 1.3 to about 2.2 millimeter.

Optical elements for use in an embodiment have a field of view of atleast eighty-five degrees and a depth of view of at least 5 mm. In someinstances, the depth of view may exceed 100 mm.

In some embodiments, a sound interface in the device, and in particular,in the control element may be coupled to a computer system to allow foruse of voice commands. In particular, it may be possible to activate adictation module during use of the device, so that the notes can berecorded. Further, voice activation may be used to activate any numberof features of the device.

Sensors and/or elements may be configured to transmit data using wiredand/or wireless connection. Sensors may be configured to interact withsensors and/or markers positioned on, in, or near a patient during useto determine a position or condition of the patient. For example, adistance and location sensor may interfaces with a computer system tonote location and distance of a scope from the insertion point of thescope. A further sensor may measure a luminal diameter and surfacefeatures of a body cavity the scope is visualizing.

An endoscope system may include a removable control element havingports, interface elements, and indicators. Further, the endoscope mayinclude an elongated element coupled to a control element having across-sectional outer diameter of less than four millimeter andincluding a conduit or channel having a diameter of at least 1.3 mm notgreater than 2.2 mm. Further the a distal element includes anillumination element and an optical element. The system further includesa computer control unit having one or more device drivers. In addition,the system may include a computer and one or more display elements.

Audio elements such as microphones may be utilized to control functionsof the system, including for example, the functioning of sensors.Further, audio elements may be used to facilitate auto-reporting,voice-activated commands, dictation, recording, and/or populatingreports and/or databases. An interface element may be configured to senddata from at least one of the optical element, the audio element and thesensor array to a computer.

In some embodiments of the endoscope device and/or system a conduit inthe elongated element may be used as a feeding tube. Unsedatedlaryngoscopy in pediatric otolaryngology and pediatric pulmonology hasbeen performed in pediatric patients. [Wood R E. Evaluation of the upperairway in children. Curr Opin Pediatr 2008; 20:266-71] Applicantshypothesized that TNE could be adapted to provide a safe and effectivetool to monitor and sample the mucosa of children with EoE. Ultra-slimflexible endoscopes were developed to create instruments that could betolerated by children, while still allowing for the removal of adequatesamples. This scope design is unique in that it can be used in pediatricnasal endoscopy, pediatric nasal bronchoscopy, and pediatriclaryngoscopy. This design differs from current adult nasal endoscopes inproduction in terms of numerous aspects including that that it isnarrower, lighter, clearer, has foot controls, has smaller accessiblehand controls to control the tip and be easier to maneuver. This scopewill also have a stiffening capability and narrow tip to allow it to beused in aerodigestive medicine and other medical and surgicalspecialties.

The present disclosure documents the performance of TNE with biopsiesusing these ultra-slim flexible endoscopes to assess the esophageal,gastric, duodenal, tracheal, and bronchial mucosa in pediatric subjectswith EoE. The performance was assessed in part through the evaluation ofparental and patient subject responses to TNE, the assessment of theability to procure samples that would be adequate to monitor disease,monitoring adverse events, and recording procedure duration and chargesgenerated. This assessment showed that unsedated transnasal endoscopyusing the pediatric nasal endoscope disclosed herein offers an excellentalternative to sedated esophagogastroduodenoscopy.

Unsedated transnasal endoscopy (TNE) in adults is safer and less costlythan sedated esophagogastroduodenoscopy (EGD). TNE with biopsies can beadapted as an effective tool to monitor the esophageal, gastric, andduodenal mucosa of children with eosinophilic esophagitis (EoE) or otherconditions of the upper gastrointestinal tract with the proper tools andtechniques. This technique can dramatically increase the safety anddecrease cost in the care of children. The present disclosure documentsthe development of the performance of TNE with biopsies in pediatricEoE.

Subjects between 8 and 17 years of age with EoE, and their parents, wereenrolled in the study. Unsedated TNE was performed. The currentlyavailable smaller endoscopes designed for bronchoscopy as a 2.8 mm (1.2mm channel) or a 4 mm flexible bronchoscope (2 mm channel) were used,and esophageal biopsies were procured. These scopes were shorter thanApplicants' currently proposed pediatric nasal endoscope and werewithout water channels, suction, air, foot control, high definitionoptics, or stiffening capability. Biopsy analysis, duration, adverseevents, and billing charges of TNE were assessed. Immediately after TNEand a minimum of 2 weeks later, the mGHAA-9 (modified Group HealthAssociation of America) and a preference questionnaire were completed,respectively.

Twenty-one of 22 enrolled subjects completed TNE. TNE was tolerated withno significant adverse events. Histopathological analysis revealed 0eos/hpf (n=12), <15 eos/hpf (n=4), and >15 eos/hpf (n=5) and totalepithelial surface area of mucosal biopsies samples from either TNEforceps compared to those obtained with standard endoscopic forceps wasnot statistically different. All parents and 76.2% of subjects wouldundergo the TNE again. TNE was preferred over EGD by 85.7% of parentsand 52.4% of subjects. mGHAA-9 revealed a high degree of satisfaction(average 43.19+/−2.6 maximum score—45). Charges associated with TNE were60.1% less than previous EGDs. The results of this study show thatunsedated TNE is a preferred, efficacious, and lower cost procedure whenmonitoring esophageal mucosa of children with EoE.

In a first aspect the present embodiment provides an endoscope forassessment of the esophageal mucosa in children. The endoscope can havea flexible endoscope shaft having a first end, a second end, a length ofabout 0.8 meters to about 1.3 meters (preferably about 0.9 meters toabout 1.2 meters, more preferably about 1.0 meters to about 1.1 meters,or about 1.05 meters), an outer diameter of between about 3.0 mm toabout 4.0 mm (preferably about 3.0 mm to about 5.0 mm, more preferablyabout 3.25 mm to about 4.0 mm, about 3.5 mm to about 4.0 mm, about 3.5mm, or about 4.0 mm) and having an inner channel lumen of about 1.5 mmto about 2.5 mm in diameter (preferably about 1.75 mm to about 2.25 mm,or about 2.0 mm). An embodiment of an endoscope includes an optionalrounded tip. A rounded tip may enhance the comfort of a patient duringuse. The lumen extends substantially the length of the shaft, and willgenerally have an opening at the distal-most portion of the second endto allow a surgical instrument to partially exit the lumen for placementof the tool in proximity to a tissue of interest. In some embodiments,the lumen extending through the length of the shaft is non-collapsable.The shaft can be configured to facilitate irrigation and suction at thesecond end of the shaft, such as by including connection to a source foran irrigation liquid and/or suction and passage across the shaft of theendoscope for the liquid and its return. The endoscope according to thefirst aspect has a handle disposed at first end of the shaft. The handlecan have a single or dual control to adjust the disposition of thesecond end of the shaft. The control enables four-way tip deflection ofthe second end of the shaft. This allows a user to direct the distal endof the shaft to facilitate visualization and sampling of desired tissuesat the distal or second end. The endoscope according to the first aspecthas an image sensor at the second end of the shaft. The image sensorfacilitates imaging of tissues at the distal end of the endoscope whenthe endoscope is inserted within a cavity of a subject. The endoscopeaccording to the first aspect has a light source disposed at the secondend of the shaft to illuminate the area surrounding the distal end ofthe shaft.

In an advantageous embodiment the endoscope according to the firstaspect can have a foot pedal or hand control to actuate suction orirrigation of the endoscope. The control can be integral to the handleto actuate suction or irrigation of the endoscope. In furtherembodiments the endoscope according to the first aspect can have acamera to facilitate visualization within the cavity of the subject. Theimage sensor can be a charge-coupled device (CCD) sensor, acomplementary metal-oxide-semiconductor (CMOS) sensor, N-typemetal-oxide-semiconductor (NMOS) sensor or a high definition video chip.

In an advantageous embodiment the endoscope according to the firstaspect can have a scope shaft stiffening component. The scope shaftstiffening component can be used to selectively reduce the flexibilityof the scope shaft. In other words, a user can selectively alter thestiffness of the shaft during use to suit the particular stiffnessneeded to execute a procedure or direct the placement of the shaft. Thescope shaft stiffening component can adapted to facilitate the use ofthe endoscope in aerodigestive medicine. Additionally, the lumen canhave an opening at the distal-most end of the second end of the shaft.This allows for the passage of instruments and for the irrigation andsuction of biological tissues through the length of the shaft and theirpartial exit from the shaft.

In a second aspect the present embodiment provides an endoscope fortransnasal endoscopy in children. The endoscope according to the secondaspect has a flexible endoscope shaft having a first end and a secondend and has a diameter dimensioned for insertion into the nasal cavityof a child, a length of about 0.8 meters to 1.2 meters, and has an innerchannel lumen configured to receive an elongate surgical instrument, thelumen extending substantially the length of the shaft. The shaft isconfigured to facilitate irrigation and suction at the second end of theshaft. The endoscope according to the second aspect has a handledisposed at first end of the shaft, the handle including a single ordual control to adjust the disposition of the second end of the shaftthereby enabling four-way tip deflection. The endoscope according to thesecond aspect also has an image sensor at the second end of the shaft tofacilitate imaging at the distal end of the endoscope when the endoscopeis inserted within the nasal cavity of a subject. Lastly, the endoscopeaccording to the second aspect has a light source disposed at the secondend of the shaft to illuminate the area surrounding the distal end ofthe shaft. The illumination source may come form an external source,such as a light source in the computer control unit, the controlelement, for example, a handle, and/or a control mechanism. The lightsource may provide light through on or more optical fibers that extendto the tip. In some embodiments, a light source may be positioned in theshaft or elongated element and utilize optical fiber that extends to thetip or distal element. In further embodiments the light source may bepositioned in the distal element or tip of the endoscope.

In an advantageous embodiment the endoscope according to the secondaspect can have a foot pedal or hand control to actuate suction orirrigation of the endoscope. The control can be integral to the handleto actuate suction or irrigation of the endoscope. In furtherembodiments the endoscope according to the second aspect can have acamera to facilitate visualization within the cavity of the subject. Theimage sensor can be a charge-coupled device (CCD) sensor, acomplementary metal-oxide-semiconductor (CMOS) sensor, N-typemetal-oxide-semiconductor (NMOS) sensor or a high definition video chip.

In an advantageous embodiment the endoscope according to the secondaspect can have a scope shaft stiffening component. The scope shaftstiffening component can adapted to facilitate the use of the endoscopein aerodigestive medicine. Additionally, the lumen can have an openingat the distal-most end of the second end of the shaft. This allows forthe passage of instruments through the length of the shaft and theirpartial exit from the shaft.

In a third aspect the present embodiment provides a second endoscope fortransnasal endoscopy in children. The endoscope according to the thirdaspect has a flexible endoscope shaft having a first end, a second end,a shaft diameter dimensioned for insertion into the nasal cavity of achild, a shaft length adapted to facilitate insertion of the shaftthrough the nasal cavity to the esophageal mucosa of a child, and aninner channel lumen configured to receive an elongate surgicalinstrument. The lumen extends substantially the length of the shaft. Theshaft is further configured to facilitate irrigation and suction at thesecond end of the shaft. The endoscope according to the third aspect hasa handle disposed at first end of the shaft. The handle has a single ordual control to adjust the disposition of the second end of the shaftthereby enabling four-way tip deflection. The endoscope according to thethird aspect also has an image sensor at the second end of the shaft tofacilitate imaging at the distal end of the endoscope when the endoscopeis inserted within the nasal cavity of a subject. In addition, theendoscope according to the third aspect has a light source disposed atthe second end of the shaft to illuminate the area surrounding thedistal end of the shaft.

In an advantageous embodiment the endoscope according to the thirdaspect can have a foot pedal or hand control to actuate suction orirrigation of the endoscope. The control can be integral to the handleto actuate suction or irrigation of the endoscope. In furtherembodiments the endoscope according to the third aspect can have acamera to facilitate visualization within the cavity of the subject. Theimage sensor can be a charge-coupled device (CCD) sensor, acomplementary metal-oxide-semiconductor (CMOS) sensor, N-typemetal-oxide-semiconductor (NMOS) sensor or a high definition video chip.The image sensor may transmit data via wires, cables and/or wirelesslyto a display. For example, in some instances data is transmitted to avideo monitor. In an embodiment, data from the image sensor istransmitted to a display that can be worn by the operator, for example,a video goggle system in use by the operator.

In an advantageous embodiment the endoscope according to the thirdaspect can have a scope shaft stiffening component. The scope shaftstiffening component can adapted to facilitate the use of the endoscopein aerodigestive medicine. Additionally, the lumen can have an openingat the distal-most end of the second end of the shaft. This allows forthe passage of instruments through the length of the shaft and theirpartial exit from the shaft.

An advantageous embodiment of the endoscope includes an audio device,such as a microphone. For example, an audio device may be positioned inthe endoscope, for example, in a control element, for example a handleand/or a control mechanism. In some instances, the audio device may bepositioned in an external component, for example, a computer controlunit and/or elements that are worn by the operator, for example,wearable electronics, such as a wearable display, for example, a videogoggle system and/or wrist display, a headset microphone, a backpackmounted microphone or the like. The audio device, for example, one ormore microphones may be integrally tied to a reporting system such thatvoice activation and/or voice dictation are allowed.

Some embodiments of the endoscope and/or system may include a sensorarray to allow the scope to report the distance traveled in the bodycavity from a point of insertion.

An embodiment of the endoscope may include a sensor array to measurevarious properties of a luminal body. For example, the sensor array mayprovide dimensional measurements of any structures found within aluminal body cavity or the luminal body itself.

The emergence of EoE has led to a renewed interest in determiningpathogenic mechanisms of esophageal inflammation and sampling of theesophageal mucosa to assess for mucosal healing. Despite the rapidprogress in establishing diagnostic criteria, treatments, and novelgenes related to pathogenic mechanisms that can significantly impact EoEpatients, limited data is available to document the natural history ofEoE. This lack of understanding has led to the present clinical practiceof multiple, high-cost, and higher-risk sedated assessments of theesophageal mucosa to ascertain whether eosinophilia has resolvedfollowing treatment. If eosinophilia resolves, a predicate determinationis made that the likelihood for EoE-related complications is diminished.If eosinophilia persists, efforts are made to resolve inflammationregardless of symptomatology, with its subsequent impact on quality oflife and costs of care. In this regard, novel devices and samplingmethodologies are urgently needed. To address this and offer a new toolin the evaluation of EoE, Applicants sought to determine if TNE couldsample the esophageal mucosa in a way that was well-tolerated andadequate. In light of the emergent need for more efficient methods ofesophageal mucosal evaluation in EoE, Applicants performed this studywithin the confines of a multi-disciplinary team to perform TNE withbiopsies in a pediatric population. Applicants chose this populationbecause of the urgent need to minimize the repetitive risks ofanesthesia, improve the understanding of EoE pathogenesis, and toultimately identify novel therapeutic targets.

Unsedated TNE is an established technique in a number of pediatric andadult subspecialties, but it has not been used by pediatricgastroenterologists. [Birkner B, Fritz N, Schatke W, et al. Endoscopy2003; 35:647-51; Dumortier J, Josso C, Roman S, et al. GastrointestEndosc 2007; 66:13-9; Dumortier J, Ponchon T, Scoazec J Y, et al.Gastrointest Endosc 1999; 49:285-91; Hu C T. Gastrointest Endosc 2010;71:11-20; Mokhashi M S, Wildi S M, Glenn T F, et al. Am J Gastroenterol2003; 98:2383-9; Mulcahy H E, Riches A, Kiely M, et al. Endoscopy 2001;33:311-6; Yagi J, Adachi K, Arima N, et al. Endoscopy 2005; 37:1226-31]A number of studies have described the advantages, limitations, andchallenges of TNE use, and in 2010, the America Society ofGastrointestinal Endoscopy developed a guideline for the use of TNE inadults. [Committee A T, Rodriguez S A, Banerjee S, et al. Ultrathinendoscopes. Gastrointest Endosc 2010; 71:893-8; Faulx A L, Catanzaro A,Zyzanski S, et al. Patient tolerance and acceptance of unsedatedultrathin esophagoscopy. Gastrointest Endosc 2002; 55:620-3; Faulx A L,Vela S, Das A, et al. The changing landscape of practice patternsregarding unsedated endoscopy and propofol use: a national Web survey.Gastrointest Endosc 2005; 62:9-15; Tatsumi Y, Harada A, Matsumoto T, etal. Current status and evaluation of transnasalesophagogastroduodenoscopy. Dig Endosc 2009; 21:141-6] This guidelineincreased attention to cost containment, and the recent upswing ininterest in esophageal diseases led to renewed interest in thistechnique. [Faulx A L, Catanzaro A, Zyzanski S, et al. GastrointestEndosc 2002; 55:620-3; Chak A, Alashkar B M, Isenberg G A, et al.Comparative acceptability of transnasal esophagoscopy and esophagealcapsule esophagoscopy: a randomized, controlled trial in veterans.Gastrointest Endosc 2014; 80:774-82; Lin L F, Shen H C. Unsedatedtransnasal percutaneous endoscopic gastrostomy carried out by a singlephysician. Dig Endosc 2013; 25:130-5; Cho S, Arya N, Swan K, et al.Unsedated transnasal endoscopy: a Canadian experience in daily practice.Can J Gastroenterol 2008; 22:243-6] A recent study also demonstrated theutility of TNE in adult's with Barrett's esophagus. [Tatsumi Y, HaradaA, Matsumoto T, et al. Current status and evaluation of transnasalesophagogastroduodenoscopy. Dig Endosc 2009; 21:141-6; Chak A, AlashkarB M, Isenberg G A, et al. Comparative acceptability of transnasalesophagoscopy and esophageal capsule esophagoscopy: a randomized,controlled trial in veterans. Gastrointest Endosc 2014; 80:774-82; BushC M, Postma G N. Transnasal esophagoscopy. Otolaryngol Clin North Am2013; 46:41-52]. To date, only one study evaluated unsedated trans oralendoscopy in children and concluded that it improved time and safety inassessing 21 children for evaluation of abdominal pain, dyspepsia, anddysphagia. [Bishop P R, Nowicki M J, May W L, et al. Unsedated upperendoscopy in children. Gastrointest Endosc 2002; 55:624-30]

With the rapidly increasing prevalence of EoE, limited knowledgeregarding its pathophysiology, and emerging clinical needs to assess theesophageal mucosa, Applicants sought to determine whether TNE inpediatric EoE would be a feasible and efficacious tool. Results ofApplicants' study reveal that patients and parents experienced withsedated EGD tolerate TNE well, and that patients and their parentsprefer TNE compared to EGD. It is likely that the limited side effectprofile and complete lack of serious adverse events contributed to thefinding that 52.4% of child subjects (4 subjects preferring neither EGDor TNE) and the 85.7% of parents (1 parent preferring neither TNE orEGD) preferred unsedated TNE to sedated EGD. In that parents often makedecisions about procedures in pediatrics and a majority of childrenprefer the procedure, these percentages are indicative of a highlysuccessful alternative to EGD. Immediate benefits of this preference forpatients include improved patient satisfaction and increased safety byeliminating anesthesia.

In many ways Applicants' results are quite similar to that reported inadult studies. For example, a large Canadian Study by Cho et al.evaluating 231 patients with an average age of 57 years for routine TNE;their study also found that TNE was well tolerated, safe and feasible.[Cho S, Arya N, Swan K, et al. Unsedated transnasal endoscopy: aCanadian experience in daily practice. Can J Gastroenterol 2008;22:243-6] This study was different, however, in that the patients wereprimarily adults, the scope used was larger (5.3 mm) and duodenalintubation was performed. Applicants' study evaluated the use of 2smaller endoscopes, smaller biopsy forceps, and TNE performance inchildren. Some areas of divergence between Applicants' findings andsimilar adult studies include that (1) in Applicants' study both theparents and child subjects evaluated the technique, (2) the adequacy ofsmaller forceps to evaluate the esophageal mucosa in EoE was assessed,and (3) the actual rather than contemplative type of future endoscopypreferred by subjects who have undergone multiple previous EGD's wasexamined. These findings augment the results of this research and itspotential application to adult and pediatric endoscopy practices.

Applicants are particularly encouraged by their findings for severalreasons. First, there was great interest in this procedure amongstpatients and parents. Applicants only needed to screen 22 subjects toenroll the 21 subjects reported here. This is likely explained by thefact that the EoE patient population represents a very engaged,experienced, and educated population that is readily seeking alternativemethods. Applicants are highly confident that this is a technicallyfeasible procedure, and are further encouraged by its overall rapidsuccess that was facilitated by a multidisciplinary pediatric teamdedicated to the care of children with aerodigestive diseases and EoE.Applicants' study provides strong support for larger studies to validatethis approach that will provide novel insights into the natural historyof EoE and significantly improve the lives of children with EoE in asafer, cost effective, and efficacious manner.

Second, Applicants' study found a high level of satisfaction andenthusiasm to repeat the TNE. The overwhelming majority of patients andparents were satisfied and preferred unsedated TNE compared to standardEGD. Subject responses in the qualitative survey identified criticalelements including the lack of anesthesia, the presence of parentsduring the procedure, the limited duration of the procedure and rapidrecovery. TNE was safe, as evidenced by the fact that no significantadverse events or event needed subsequent treatment or evaluation. Thesubjects and parents appreciated the improvement in their quality oflife with TNE, as it allowed them the ability to return to school andwork and eat shortly afterwards. In fact, several families noted thepatients returned to school or a sport activity after the TNE. The timeat CHCO for a standard EGD is 3 hours compared to 60-90 minutes for theTNE, a time that included not only the TNE but also research protocoldocumentation. This 3-hour procedure center time for EGD usuallyincludes check in, pre-operative evaluation by nursing,gastroenterology, and anesthesia, the procedure itself, recovery, anddischarge instructions. The 60-90 minute time for TNE in clinic includedresearch documentation, pre-procedural documentation, the procedureitself, and discharge instructions. Most of these improvements in timereduction and increased satisfaction, noted above, are related to theeffects of eliminating anesthesia or sedation for TNE. Not only doesthis practice seem to improve satisfaction of patients and parents, butthere is also a significant likelihood it decreases the risk of adversemedication reactions, aspiration, and possible effects on the developingpediatric brain. [Gleich S J, Flick R, Hu D, et al. Contemp Clin Trials2014; 41C:45-54] This is an emerging concern amongst pediatricanesthesiologists. While pediatric subjects without sedation or generalanesthesia noted a mild sore throat and gagging, this was minor enoughthat the majority chose follow up TNE for their EoE evaluation aftertheir initial study procedure. This has been confirmed as more than ahypothetical question, with several of Applicants' subjects requestingfollow up TNE after the study concluded.

The third positive outcome of Applicants' study relates to the integrityof the mucosal sample. Regarding the techniques effectiveness inevaluating mucosal esophageal sample, Applicants found that theepithelial surface area needed for eosinophil count evaluation was notsignificantly different from the standard EGD 2.8 mm biopsy forcepscompared to either of the TNE 2 mm or 1.2 mm biopsy forceps. Thisfinding provides a high level of confidence that the sample procured atthe time of TNE will have the same surface area compared to thatobtained with the gold standard EGD biopsy forceps. The 2 mm forcepswere also able to procure lamina propria.

The final areas of interest in this study were the reduction in cost andincrease in efficiency. Financial benefits of TNE include the fact thatTNE incurred fewer charges and required less time away from work andschool when compared to a standard sedated pediatric EGD. The projectdemonstrated a significant 60.1% drop in charges. The majority of thisreduction in cost is related to the lack of anesthetic/anesthesiologistduring TNE. The significance of this cannot be understated. For example,if Applicants' institution were to perform 100 sedated EGD's per yearfor EoE at a hypothetical average, non-insurance adjusted charge of$9,390 dollars per general anesthesia provided endoscopy encounter, thiswould accumulate $939,000 total charges per year for EoE. This wouldinclude all facility charges, physician, pathology and anesthesia fees.If these 100 EGDs for EoE were converted to unsedated TNE, this couldtranslate to a healthcare systems charge savings of $564,000 dollars peryear. These are possible charges however and not respective insurancerates.

Several areas will be addressed in future evaluations. First, forpractical reasons, Applicants needed to use 2 different sized endoscopesfor TNE. Future work will standardize this for patient comfort andbiopsy size. Second, although the 1.2 mm forceps were not able toprocure lamina propria, the 2 mm forceps in this study were able toobtain lamina propria. While this section of the tissue has been used tograde fibrosis, this metric has not been standardized or become a goldstandard for clinical assessments. Applicants' study demonstratesfeasibility in pediatrics, but evaluating a much larger cohort isrequired to achieve a significant power for safety and other metrics.Power analysis based on Applicants' own institution's quality and safetydata would necessitate over 10,000 endoscopies to find a singlesignificant adverse event. This could be remedied with the developmentof further databases, as this technique is increasingly used atApplicants' institution or in a national program evaluating its use inpediatrics. Finally, Applicants undertook this study in amulti-disciplinary collaboration with their pediatric pulmonary andotolaryngology colleagues. This was done for study design to maximizepatient comfort during TNE development in pediatrics, a strong interestin aerodigestive and eosinophilic disorders by gastroenterologists,otolaryngologists, and pulmonologists alike, and the need for a morepragmatic multi-disciplinary approach to diagnosing and managing EoE asit presents in different single specialty clinics. Since the studyinitiation, the gastroenterologist, otolaryngologist, and pulmonologistshave been trained in single physician TNE with biopsies that furtherimproves cost and efficiency, diagnosis, and referral for management ofEoE.

In conclusion, the implementation of TNE in pediatric gastroenterologyfor the evaluation of pediatric EoE is safe, preferred by patients andparents alike, and has the potential to dramatically reduce costs. Thusit appears that TNE would be measured as a highly effective practice inpediatric EoE management per Berwick's description of the triple aim:the pursuit of improved experience of care, the health of populationsshould be improved, and the cost of per capita healthcare should bedecreased. [Berwick D M, Nolan T W, Whittington J. Health Aff (Millwood)2008; 27:759-69] This suggests that TNE use should be highly consideredas an alternative to standard sedated EGD or esophagoscopy for thefollow up evaluation of pediatric EoE. The technique will continue to berefined and improved, offering more opportunities for its use inmonitoring response to therapeutics, obtaining follow-up evaluations,and performing research in EoE.

Turning to FIG. 4, a pediatric nasal endoscope 10 was developed toperform TNE in children. The pediatric nasal endoscope 10 includes aflexible endoscope shaft 20 constructed from medical-grade slippery(such as a hydrophobic) material with a slick coating having a length ofabout 1.05 meters and a width of about 3.5 mm. The flexible endoscopeshaft 20 has a biopsy channel 30 running the length of the endoscopeshaft and is adapted to slidingly receive a pediatric nasal endoscopebiopsy forceps 70 (See FIG. 3) within the lumen of the channel or allowsuction or irrigation. 30. The distal end 40 of the flexible endoscopeshaft 20 is rounded and can be flat or if the end user wishes designedto be terminated with an optional, removable soft silicone tip 41. Thedistal end 40 of the flexible endoscope shaft 20 also includes a highlumen LED 42 to provide light at the tip and a high-resolution videocapture device 44 to capture images or video in the region of the distalend 40 of the flexible endoscope 20. The proximal end 50 of the flexibleendoscope shaft 20 can include a single 4-way tip deflection controllever 52 to control the displacement of the endoscope's tip, a button 54to actuate photo or video and/or autotranscription features associatedwith a reporting system capabilities of the endoscope, a hand control 56to operate air and/or water suction, a line out 57 to a imaging systemsuch as a computer monitor, an optional scope stiffening device 58 toallow its use in aerodigestive medicine. A foot pedal 60 can also becoupled to the endoscope to activate and control water flow and airsuction and/or other control features of the scope.

As discussed above, the flexible endoscope shaft 20 has a biopsy channel30 running the length of the endoscope and is adapted to slidinglyreceive a pediatric nasal endoscope biopsy forceps 70 (See FIG. 5)within the lumen of the channel 30. Turning to FIG. 5, an exemplarypediatric nasal endoscope biopsy forceps 70 is illustrated. Thepediatric nasal endoscope biopsy forceps 70 has a length of about 1.2meters, which is slightly longer than the length of the biopsy channel30, a width of about 2 mm, and opposing ends forming a distal end 71 anda proximal end 72. The distal end 71 includes a cupped and spiked tipwith an opening of about 2.8 mm to 5 mm when fully open. The proximalend 72 includes an actuator to open and close the tip at the distal end71 of the forceps 70. Examples 1 & 2, presented below, document thedevelopment of the transnasal endoscopy/esophagoscopy (TNE) to assessthe esophageal mucosa in children using the pediatric nasal endoscope.

Further embodiments of endoscopic devices, elements thereof, and/orsystems utilizing endoscopes are described herein. Endoscopes may beused in combination with other elements in a system to enhance thecapabilities of the scope and/or increase a number of uses for which thescope may be used.

A system including endoscope 62 is shown in FIG. 6. As shown, endoscope62 includes distal element 63, elongated element 64 and control element65. An endoscope may be coupled to external supplies and/or reservoirsof materials. As shown in the illustrative example of FIG. 6, endoscope62 is coupled to air supply 66, liquid supply 67, and suction 68. Inaddition, endoscope 62 includes interface elements 69, 73. Endoscope 62is coupled to computer control unit 75 and computer 76.

The control element may include a port or a number of ports which areused to provide and/or removal materials to/from a target area. Forexample, ports may be used to supply and/or remove fluids to/from atarget area, such as water, air, and/or medications in specific measuredamounts. In some embodiments, an interface element may be configured todeliver one or more pre-determined amounts of water, air and/or medicineduring use by the operator based on a procedure, protocol, patient needs(for example, patient size) and/or preferences of the operator. Inalternate embodiments, an interface element may be configured to removepredetermined amounts of fluids.

In some instances, suction may connected to a port in order to providesuction to a target area. Ports may include coupling structures tocouple various delivery systems to the control element.

Some embodiments of control elements may include interface elements. Forexample, an interface element may be used to control the positioningand/or functions of distal element, a portion of the elongated element,the function of devices and/or sensors positioned along the elongatedelement and/or the distal element. In particular embodiments, aninterface element may be used to determine a distance from an insertionpoint and/or measure luminal body findings. For example, determining adiameter of lumen, such as an esophagus or bronchus, and/or measuringthe size a lumen and/or findings therein, such as a gastric polyp orulcer. For example, interface elements may control aspects of theoptical system. In some embodiments, interface elements may controlimage capture, video, and/or audio recording.

For example, as depicted in FIG. 6, interface element 69 may control theimaging element. In particular, in some instances, an interface elementmay be programmed such that different user interactions may berecognized by the system as different commands. In particular, interfaceelement 69 may be programmed to capture an image upon a momentary touch.In contrast, interface element 69 may be programmed to start and/or endvideo capture when interface element is pressed and held. Further,interface element 73 may be programed such that a touch, for example, amomentary touch, may provide an instruction that the device willauto-populate a section of a report, while a press and hold motion willinstruct the device to record audio. For example, the auto-populatefeature would enable audio to be transmitted from the microphone in thecontrol element to a reporting system where it would be transcribed intoa report system automatically.

In some embodiments, an auto-populate feature may be used to populateany portion of form with transcribed audio data, audio files, videofiles, metrics measured by sensors, in particular, dimensions, positionof the endoscope, and/or other physiological conditions within a body orportion of the body being viewed.

A control element may include a steering mechanism. For example, FIG. 6depicts user interface 74 which may be used as a steering mechanism. Insome embodiments, the steering mechanism will be a four-way mechanism.For example, the steering mechanism may be constructed along the linesof a joystick and/or roller ball to allow for single hand manipulationand steering.

The control element may have a housing constructed using standardmethods known in the art, as well as newly developed technologies. Forexample, the control element may have a housing that is constructedusing three dimensional printing.

FIGS. 7A-B depict an exploded partial cut-away views of endoscopes 77.In particular, as shown in FIG. 7A, distal element 63 is positionedproximate steering collar 78 which is positioned proximate to elongatedelement 64. As shown, a portion of imaging element 79 extends from thedistal element while a portion is positioned in conduit 22 of distalelement 63 and extends through steering collar 78 and into conduit 24 ofthe elongated element 77

The distal element of the endoscope may have a rounded end, a flat end,and/or a combination. In some embodiments, an end of the distal elementmay include a soft tip, for example, a soft silicone tip.

Various embodiments of an end view of a distal element are depicted inFIGS. 7A, 7B, 8, 11, 15, 18, 22, 26, 29. Distal elements may beconstructed from one or more materials including, but not limited toplastics such as acrylonitrile butadiene styrene (ABS), polycarbonate(PC), polycarbonate-acrylonitrile butadiene styrene (PC/ABS), highdensity polyethylene (HDPE), polyamide (PA), polyether ether ketone(PEEK), polypropylene (PP), and/or polyvinyl chloride (PVC), metals suchas aluminum, stainless steel, carbon steel, titanium, and/or magnesiumand/or combinations thereof. The materials depicted in these variousembodiments may be combined based on the needs of the use. Anillustrative example of the distal element includes stainless steel.

Elongated elements 77 of FIGS. 7A-B, include steering collar 78,extruded element 26, tubular element 28 and shrink element 29. As isshown in FIGS. 7A-B, extruded element is surrounded at least in part bytubular element 28, which is in turn surrounded by the shrink element29. As can be seen in both FIGS. 7A-B, steering guides 25 are positionedwithin groove 27 on the extruded element 26. FIG. 7A depicts steeringguides connected to the steering collar 78 at groove 27.

As shown in FIG. 8, an end of distal element 80 shows multiple conduits82, 83, 84. In an embodiment, conduits 82, 83, 84 may be used to housedevices and/or portions thereof that are necessary for the functioningof the endoscope. In particular embodiments, one or more of the conduitsmay be used to house optical fiber. Depending on the design of theendoscope and positioning of various elements therein the conduits mayextend from the distal end to the proximal end of the elongated element.In alternate embodiments, one or more of the conduits may extent from amiddle of the elongated element to an end. For example, if aillumination source is positioned at point corresponding to a middle ofthe elongated element, a conduit that houses the optical fiber toprovide light to the distal element may run from the distal element tothe position of the illumination source located at the middle of theelongated element.

Distal element 80 includes channel 85. As shown in FIG. 8, channel 85may be partially open. FIG. 9 depicts a cross-sectional view of FIG. 8along line A-A. As shown in FIG. 9, distal element 80 includes conduit82 and channel 85 both of which extend along the length of distalelement 80. As can be seen, a geometry of conduit 82 may vary along alength of the distal element. For example, an inner diameter can bevaried. An outer diameter of distal element may also vary. For example,as can be seen in FIG. 9 such that it may be fitted to an elongatedelement. As can be seen in FIG. 9, a face of the distal element 80 isshaped.

FIG. 10 depicts a perspective view of an embodiment of a distal elementhaving a single conduit 102 and an open channel 104. Further, it can beseen in FIG. 10, that the outer diameter of the distal element 100varies its length. Coupling section 106 has a smaller diameter than therest of distal element. The coupling section may be constructed in amanner such that it couples to an elongated element.

FIG. 11 depicts an end of distal element 110 having multiple conduits112, 114. Conduit 114 is cut using a swept cut path. FIG. 12 depicts across-sectional view of distal element 110. As can be seen in FIG. 12, apath of conduit 114 varies along a length of the distal element. Inparticular, the path of conduit 114 moves from an edge of the distalelement 110 toward a middle of the distal element 110. A geometry ofconduit 112 changes along a length of distal element 110. As can be seenin FIG. 12, a section of conduit 112 has a rectangular geometry and afurther section of conduit 112 has a substantially circular geometry. Asshown in FIG. 12, an outer diameter of the distal element 110 variesalong the length of the distal element.

FIG. 13 depicts a perspective view of distal element 110 shown in FIGS.11, 12, 14. As can be seen in FIG. 13, conduit 112 includes cut-outs132. Cut-outs may conform a shape of devices, tubing, and/or otherelements. In some instances, cut-outs may help to elements placed withina conduit. As shown in FIG. 13, an outer diameter and geometry is variedalong the length of the distal element 110. Cut-out 134 is positioned onan outer surface of distal element 110. In some embodiments, cut-out 134may be designed to couple with an elongated element.

An embodiment may include a cut-out designed to house a device such as asensor, imaging element, light, or the like, cable, wire, and/or fiberoptic element. FIG. 14 depicts a top perspective view of distal element110. From this view, the variation of the geometry along the length ofthe distal element is visible.

As shown in FIG. 15, distal element 150 includes multiple conduits 152,154, 156 and channels 156. Conduit 152 has a larger diameter that theremaining conduits. Conduit 152 may act as a working conduit. Channels156 are partially open. In some embodiments, channels that are partiallyopen may house a camera sensor and/or optical fiber.

FIGS. 16-19 depict various views of a distal element constructed usingsliced layers. Sliced layer construction may allow for more complicatedgeometries. Processing limitations of standard construction methods maylimit design given size ranges of these elements, thus, it may bedesirable to used sliced layer construction and/or additivemanufacturing, such as three dimensional printing. For example, a slicedlayer construction process may enable the use of a swept cut path in aconduit of the distal element.

As shown in FIGS. 16-17, the sliced layers allow for changing anelevation of conduit 162 along the length of the distal element. Conduit164 varies in geometry along a length of the distal element 160. FIG. 18depicts a perspective view of distal element 160. Distal elementincludes conduits 162, 164, as well as channels 166.

As illustrated in FIGS. 20-23, distal element 202 is constructed frommultiple sections. Use of multiple sections in the distal element mayinhibit undercuts. Distal element 202 includes conduit 204, as well asopen channel 206. As depicted in FIG. 20 showing an end view of distalelement 202 which includes channels 208 for lighting elements such as alightpipe, fiber optic elements, or clear epoxy. FIG. 21 depicts across-sectional view of distal element 202 shown in FIG. 20 along lineA-A. Light source 210 is positioned proximate conduit 204 such that thelight source provides light to a target area through channels 208. Lightsource may include, but is not limited to Xenon lights, organiclight-emitting diode (“OLED”) lights, light-emitting diode (“LED”)lights, for example, high lumen LEDs. FIGS. 22-23 show channels 222positioned on an outer surface of the distal element 202.

FIG. 24 depicts an end view of distal element 240 constructed fromflexible member 242 and rigid body 244 which define conduit 245. Conduit248 is depicted clearly in FIG. 25 which shows a perspective view of thedistal element. A side view of the distal element 240 is shown in FIG.26.

FIG. 27 illustrates an end view of a distal element having an egg shapedface. Distal element 270 includes conduits 272, 274, 276. Across-sectional view of FIG. 27 along line A-A is shown in FIG. 28.Conduits 272, 276 are both shown having varying diameters along thelength of the distal element. Conduit 272 may be a working conduit orworking channel. In an embodiment, conduit 276 may house an opticalsensor.

FIGS. 29-30 depict a perspective view and a top view of distal element270, respectively. Channels 292, 294 are positioned on an outer surfaceof distal element 270. FIG. 30 clearly depicts the varying outerdiameter along the length of the distal element.

Overmold drawings reflect a tool necessary to create the distal element.Various configurations were constructed that corresponded to thegeometries of the distal element as can be seen in FIGS. 31-33.

As shown in FIG. 9, distal element 80 includes conduit 82 and channel 85both of which extend along the length of distal element 80. As can beseen, a geometry of conduit 82 may vary along a length of the distalelement. For example, an inner diameter can be varied. An outer diameterof distal element may also vary. For example, as can be seen in FIG. 9such that it may be fitted to an elongated element. As can be seen inFIG. 9, a face of the distal element 80 is shaped.

The scope may include a distal element having openings for additionaldevices or elements. For example, the distal element may includeopenings for an illumination element, such as a fiber optic cable,light, and/or light source, and/or an optical element, such as a camera.

An optical element may include a device having a field of view ofgreater than 60°. In some embodiments, the field of view of the opticalelement may be greater than 85° or as high as 150 degrees. Further, thedepth of field may be as small as 5 mm greater than 15 mm. In someinstances, the depth of field may be greater than 19 mm. An opticalelement such as a camera, for example, a high definition camera orvideoscope may include devices such as, but not limited to miniaturevideoscopes.

The distal element may also include openings which may allow formanipulation at a predetermined location, delivery of materials, such asair, liquid, medicines, devices, etc., and/or retrieval of materials,such as tissue, devices, fluids. In an embodiment, the distal elementmay include an opening which allows for use of suction at apredetermined location and/or a target area.

Elongated elements may couple to both the distal element and the controlelement. A length of length of an elongated element may be in a rangebetween 0.5 to 1.5 meters. For example, an elongated element may have alength in a range from about 0.8 to 1.2 meters in some embodiments. Anouter diameter of an elongated element may be less than about 4.5millimeter. In some embodiments, the outer diameter of an elongatedmember may be less than 4.0 millimeter. For example, an elongatedelement may have an outer diameter of less than about 3.5 millimeters inan embodiment.

A stiffness of the elongated element may vary along its length. At leasta portion of the length may be flexible. In some embodiments, variablestiffness along the length of the elongated element may be created usinga stainless steel tube that is laser cut with a variable interruptedspiral pattern. The more cuts, the more material is removed and the moreflexible the shaft becomes. Thus, an elongated element may be designedto have a stiffer area proximate the control element such that torquecam be transferred, while being flexible proximate the distal elementsuch that tight bends can be negotiated and/or patient comfort improved.In an alternate embodiment, the elongated element may include a braidedmetal section to provide variable stiffness.

In some embodiments, a length of a flexible portion of the elongatedelement may be in a range from about 30 to about 50 millimeters. Forexample, a flexible portion of an elongated member may have a length inrange from about 35 to 45 millimeters. In an embodiment, the length ofthe flexible portion of the elongated element may be approximately 40mm.

An elongated element may include one or more conduits. The conduits mayhave various configurations. For example, the conduits may be coaxial,positioned proximate each other, and/or positioned on opposite sides ofthe cross-section of the elongated element. Conduits may include one ormore lumen. For example, a conduit may be a multi-lumen.

Conduits may act as a housing for elements inserted into the elongatedelement. In some embodiments the elongated element may have one or moreconduits configured to receive devices and/or sensors to provide accessto a target area.

In some embodiments, conduits may provide a path for materials to reachthe distal element and/or a target area. Further, a conduit may be usedto transport materials from the target area to control element or, insome cases, to a position external to the control element.

Elongated element 62 includes conduit 24 running the length of theendoscope elongated element. In some instances, the conduit mayslidingly receive instruments, such as a nasal endoscope biopsy forceps70 (See FIG. 3) within the lumen of the conduit and/or allow suction orirrigation.

A working conduit in the elongated element may have an inner diameter ofgreater than about 2.0 millimeters. Further, the inner diameter ofworking conduit may be greater than about 2.1 millimeters in someembodiments.

At least one conduit through the elongated element may have an innerdiameter of greater than about 1.3 millimeters. Some embodiments mayinclude conduits having an inner diameter of about 1.4 millimeters orgreater.

A sensor array may be used to take measurements throughout a procedure.For example, a sensor array may make distance measurements, for example,the distance that an endoscope has traveled in the body, luminalmeasurements, such as diameters, lengths, and/or volumes, quantitativechanges, physiological measurements within the body, such astemperature, pulse oximetry measurements, and/or etc.

An endoscope may include an elongated element having a flexible section.This flexible section of the elongated element may be constructed from amedical-grade material. In particular, a hydrophobic material may beused. Hydrophobic materials may create a slippery surface which allowsthe device to be inserted with more ease and/or less discomfort to thepatient.

Elongated member 62 of endoscope also includes imaging element 79 andillumination element 36. For example, a high lumen LED may be used toprovide light and a high-resolution video capture device may be used tocapture images and/or video in the region of the distal end of theendoscope.

As shown in FIGS. 6 and 34-42, control elements may include anycombination of ports, interface elements, and/or indicators. In someinstances, an interface element may include a steering element which maycontrol the movement and/or displacement of the distal element and/oroptical element of the endoscope. For example, the degrees of deflectionfrom the normal position for the distal element may be greater than 90°in at least one direction. For example, the degrees of deflection fromthe normal position for the distal element may be 90° in threedirections and greater than 90° in a fourth direction. Deflection may beachieved by pulling on steering guides, for example, steering wires.

Interface elements may be positioned on a control element to provide forease of use of the operator. For example, in some embodiments, interfaceelements may be positioned along a top surface, a side surface, and/oran underside of the control element. An embodiment of an interfaceelement may act in a joystick-like manner to control movement of thedistal element.

FIG. 34 depicts a control element 3602 which is designed such that itconforms to the shape of a hand. Interface element 3604 is controlled ina manner similar to a roller ball for ease of use. Further, interfaceelements 3606, 3608, may be control audio recording and image capture,respectively. In some embodiments, interface element 3606 may controlaudio recording and transcription. These interface elements may havemultiple settings. For example, a quick press may take an image orrecord a predetermined amount of audio, while pressing and holding theseelements may activate video recording or extended audio recording.Further, the interface elements may be programmed to initiateauto-reporting data to one or more reports, databases, or processors.Data may include, for example, audio, visual, positioning, and temporaldata, as well as physical and physiological measurements.

In some instances, the functionality of the interface elements may beprogrammable by a user for ease of use. In alternate embodiments, thefunctionality of the interface elements may be defined by a use of thedevice. For example, when then endoscope device is used to monitor afeeding tube the needs may be different from when the endoscope deviceis used to conduct a TNE. FIG. 35 depicts a front perspective view ofcontrol element 3702 which conforms to the shape of a hand. As can beseen in FIG. 35, ports 3704, 3706 may be positioned such that they donot interfere with the interface elements and the user's ability tocontrol aspects of the endoscope. For example, port 3704 serves as aconnection point for suction while port 3706 allows for a connection offluids, in particular, air and/or water. Port 3708 provides access to aconduit and/or channel that runs through elongated element 3710.

In some embodiments, the control element may include multiple ports. Atleast one port may provide access to a a channel and/or conduit withinthe elongate member. An insertion element, for example an instrument maybe inserted into a conduit of the elongated element using a port.Further, an instrument may be coupled to a control element at aportwhich provides access to a conduit and/or channel within elongatedelement. An insertion element may include, but is not limited to aninstrument, such as forceps, in particular, biopsy forceps, a feedingtube, a cable for sensors, sensors, accessory, illumination elementsand/or optical elements. Further, interface elements may be positionedon a control element such that it provides easy maneuverability of thedistal element.

In some embodiments, after positioning of an instrument within theelongated element, the control element may be removed. Wires and/orconnectors to various elements, for example, audio and imaging elements,sensors, and the like may be remain so that these elements can be used.

FIG. 36 depicts a rear perspective view of a further embodiment of acontrol element. Control element 3902 includes interface elements 3904,3906, 3908, 3910, 3912. Port 3914 connects to line 3916 which mayconnect to a computer control element, a display, and/or a computer. Insome instances, port 3914 is used to provide suction, air, and/or water,as well as house electronics. Interface element 3906 may be used toactuate photo or video capabilities of the endoscope, while interface3904 may be used to control audio input. Interface elements 3910, 3912may be used to control movement of the distal element, for example, viaa steering collar (shown in FIGS. 7A-B) in part. Interface element 3908controls an amount and/or duration of fluid provided to a target areavia the endoscope. For example, interface element 3908 may be programmedto deliver predetermined amount of fluid over a predetermined timeframe. These settings may be controlled by a user and/or by protocolsdesigned for each use of the endoscope. In particular, a short twist ofinterface element 3908 may deliver 5 mL bursts of water to the targetarea.

FIG. 37 depicts a side view of control element and illustrates theergonomic design of the control element. Port 4006 provides a connectorfor suction, so that suction can be provided to a target area. Port 4004provides a connection for fluids which may be delivered to a targetarea. An amount of fluid and/or type of fluid may be controlled usingthe interface element 4012. Interface element 4014 controls thepositioning of the distal element. Port 4008 provides access to thetarget area via a conduit running through the elongated element forinsertion element 4010.

In some embodiments, there may be a scope stiffening element to allowuse of the endoscope in aerodigestive medicine. For example, a wire maybe used as a stiffening element in the elongated element.

Additional interface elements may be used to control various aspects ofthe device. For example, foot pedals may be used to activate and controlfluid flows and/or suction, control imaging devices and/or audiodevices. Input devices capable of providing information to the varioussystems may include interface elements, for example, buttons, joystics,tracker balls, foot pedals, virtual reality devices, goggles, glasses,and the like, sensors, imaging elements, audio elements, and/or anydevice configured to report a value.

In some embodiments, an interface element may be programmed to interactwith a specific a behavior of the operator to achieve a desired outcome.Thus, it may be possible to customize the inputs based on the needsand/or desires of a user and/or a use. For example, some users mayprefer a specific configuration of interface elements that combine inputfrom one or both hand and/or one or both feet. Further, some protocolsmay require specific movements from a user that may make it desirable toalter the inputs so that the user has an increased ability to use theirhands for other purposes.

As discussed herein, the elongated element 4107 has a conduit runningthe length of the endoscope and is adapted to slidingly receive aninserted element, such as biopsy forceps, through port 4106 and into alumen of the conduit. Control element 4102 also includes port 4110 forconnecting to the computer control unit, a computer and/or a display.Ports 4112, 4114 may be configured to deliver fluids and/or such to atarget area via the endoscope.

FIG. 38 depicts a side view of a further embodiment of a control element4202. Interface elements 4204 may be used to control what is occurringat a target area. Ports 4206, 4208, 4210 may be used to provide inputsand/or remove materials to a target areas.

As shown in FIG. 39, control element 4302 may be connected to a computercontrol element 4304 via cables 4306. Further, the control element maybe connected to a computer and/or a display. FIG. 39 depicts positionsfor a light source for use with the endoscope. In some embodiments,light source 4308 may be positioned proximate and/or in distal element4310. A light source 4312 may also be positioned in control element4302. Further, light source 4316 may be positioned on computer controlunit 4304. Regardless of the position light may be provided to anillumination element positioned on distal element 4310 using opticalfiber.

The computer control element may be designed to sit on a bench. A sizeof the computer control element may be less than thirty centimeters by16 centimeters by 10 centimeters. In some cases, the computer controlelement may be designed to be portable for easy transport.

As is shown in FIG. 40, endoscope 4402 may be connected to computercontrol element 4404 using cables 4408 and optical fiber 4406. Inparticular, optical fiber 4406 may connect light source 4410 in computercontrol element 4404 with illumination elements positioned on the scope.

Images captured on the imaging element may be displayed using a computerconnected to the computer control element. FIG. 40 depicts anillustrative example of a system including endoscope 4402 coupled to acomputer control unit 4404 that includes multiple drivers 4412, 4414 Inparticular, an optical element controller 4412 is positioned within thecomputer control element 4404. Data may be transmitted from the opticalelement controller 4412 to computer 4416 and/or display 4418. Inaddition, processor 4414 may alter data from the optical elementcontroller prior to providing it to computer 4414.

During a procedure, a screen connected to the computer will becontrolled by software such that information and/or images related to apatient and/or procedure are displayed on the screen. As shown in FIG.41, software may have a setup form 4500 which shows up on a display.Fields on the setup form may vary according to the requirements of thephysician, hospital, and/or procedure.

Images, forms and/or reports may be generated by the computer from oneor more inputs from a program, a user, an audio element, an imagingelement, and/or sensors. The computer may follow a predeterminedalgorithm that displays various images depending on the type ofprocedure performed. For example, FIG. 42 depicts a display for useduring a procedure which shows live stream video 4600, a static image4602 and/or report 4604 These fields may be determined by an end-user,such as a physician, a hospital, or the like. Using the computer, thesystem may be designed to auto-report. In some instances, this may occurbased on a predetermined time interval, movement interval and/or event.Further, auto-reporting may be controlled by an end-user.

Uses for the herein described devices and/or systems may be varied. Forexample, the devices and/or systems described herein may be used todeliver medications to a target area, remove tissue from a target area,for example to conduct a biopsy, to promote cessation ofbleeding/cautery, to remove a foreign body, to collect samples from atarget area, in particular bodily fluids, study target areas, inparticular the gastrointestinal tract, to evaluate existing and/orpotential disease by examining tissues, in particular,pharynx/larynx/esophagus/stomach/small intestine tissues, to diagnosedisease or conditions, for example, celiac disease, infection, etc.,and/or to manage airways, among others.

The present invention also contemplates the use of the herein disclosedendoscope for measuring an airway, dilation of an airway,gastrointestinal (GI) tract and/or throat as well as placement ofenteral feeding tubes and body devices in an airway and GI tract.

The treatment of an airway with the treatment device disclosed in U.S.Pat. No. 9,358,024 involves placing an endoscope. The treatment deviceis then inserted through or next to the endoscope while visualizing theairways. Alternatively, the visualization system may be built directlyinto the treatment device using fiber optic imaging and lenses or a CCDand lens arranged at the distal portion of the treatment device. Thetreatment device may also be positioned using radiographic visualizationsuch as fluoroscopy or other external visualization means. The treatmentdevice which has been positioned with a distal end within an airway tobe treated is energized so that energy is applied to the tissue of theairway walls in a desired pattern and intensity. The distal end of thetreatment device may be moved through the airway in a uniform paintinglike motion to expose the entire length of an airway to be treated tothe energy. The treatment device may be passed axially along the airwayone or more times to achieve adequate treatment. The “painting-like”motion used to exposed the entire length of an airway to the energy maybe performed by moving the entire treatment device from the proximal endeither manually or by motor. Alternatively, segments, stripes, rings orother treatment patterns may be used.

Sensor elements disposed in the sheath body disclosed in U.S. Pat. No.8,926,501 may be configured so as to provide sensing contact with aspace exterior to the sheath, such as an airway between the sheath and apatient's throat or other body orifice, a blood vessel in a vascularimplementations, or other body orifices such as those in the digestivesystem or excretory system. In some implementations, sensors may bedisposed in the body so as to be in contact with a space interior to thesheath, such as a space between the interior surface of the sheath andan inserted endoscope. Sensors may be disposed in the body by attachmentto the body on the interior or exterior, such as by use of adhesives orother attachment materials, by molding or forming into the body, or byother attachment or forming methods known or developed in the art.

Physical conditions of interest may include pressure, temperature, flowrate (based on, for example, flow of a gas such as air through an airwayor fluid, such as blood, through a flow channel such as an artery orvein), pH, cross-sectional distance measurements (such as measurement ofcross-sectional areas of a gas or liquid flow channel, such as the nasalpassages or throat), acoustic information (audible sounds or otheracoustic information), blood pressure, pulse, and the like.

In an exemplary embodiment, a sensor element comprises a pressuresensor, configured to measure pressure at or near a location beingimaged by the endoscope. A pressure sensor may also include one or moreadditional sensor elements. For example, in one embodiment, a sensorelement comprises a pressure sensor and temperature sensor, such as aMEMS based circuit like the SCP1000 device manufactured by VTITechnologies, which is configured to measure both pressure andtemperature at or near the location being imaged. Other similar orequivalent devices known or developed in the art may also be used invarious implementations.

Research and analysis by the inventors of the technology disclosedherein in the area of airway physiology and airflow characteristics hasshown a relationship between pressure values and airflow restrictions inbreathing channels, such as through airways like the nose, palate, andrear portion of the mouth and throat. These may be associated withconditions such as airway restriction and sleep apnea, or otherbreathing issues. While a conventional endoscope may provide somevisualization of an airway restriction, additional information of valuemay be added by acquiring pressure data, acoustic data, body conditionssuch as blood pressure, pulse, temperature and/or other sensor datasimultaneously with visual information such as images or video providedby the endoscope. In particular, it may be advantageous to obtain thisadditional sensory information and map or fuse it to the associatedimaging data obtained by the endoscope camera to provide an image ordisplay of the combined data and image or images in two or threedimensions.

The present invention also encompasses a method for determiningproperties of a body lumen at different states with an endoscopicinstrument as disclosed in U.S. Pat. No. 8,696,547. The method of the'547 patent involves providing a computer having a processor configuredto: acquire a first set of 3D image data of a body lumen at a firstlumen state; acquire a second set of 3D image data of the body lumen ata second lumen state, the body lumen having a different shape in thesecond lumen state than in the first lumen state; determine from thefirst set of previously acquired 3D image data a first property at eachlocation along the body lumen; determine from the second set ofpreviously acquired 3D image data the first property at each locationalong the body lumen; register the first property at the first lumenstate to the first property at the second lumen state at each locationalong the body lumen, thereby mapping the first property at the firstlumen state and the first property at the second lumen state for eachlocation along the body lumen; estimate an endoscopic instrumentposition of the endoscopic instrument relative to the body lumen whenthe endoscopic instrument has been advanced into the body lumen; andautomatically identify in real time at least one of the following: thefirst property at the first lumen state based on the endoscopicinstrument position and the mapping, and the first property at thesecond lumen state based on the endoscopic instrument position and themapping.

The present invention also encompasses a method for continuous guidanceof endoscopy during a live procedure as disclosed in U.S. Pat. No.8,672,836. The method of the '836 patent involves the steps of: a)providing a precomputed data-set based on 3D image data, the data-setincluding reference information representative of a predefined routethrough a body organ to a final destination, the reference informationincluding virtual endoscopic (VE) image data representing one or more ofthe following: 3D organ surfaces, 3D routes through an organ system, and3D regions of interest (ROIs); b) displaying a plurality of live realendoscopic (RE) images as an operator maneuvers an endoscope within thebody organ; c) presenting information, corresponding to an initialreference location along the predefined route, which enables anendoscope operator to move the endoscope toward the reference location;d) invoking a registration/tracking algorithm that registers the VEimage data to one or more of the RE images and continuously maintainsthe registration as the endoscope is locally maneuvered; e) presentinginformation corresponding to another reference location along thepredefined route, which enables the endoscope operator to move theendoscope close to this new reference location; f) repeating steps d)-e)a plurality of times until the endoscope is within the vicinity of thefinal destination; and g) when the final destination is within the fieldof view of the endoscope, providing additional information enabling theendoscope operator to decide on a final maneuver for the procedure, theadditional information including an icon, other the ROI itself,superimposed on at least one of the VE and RE images to visuallyindicate a direction from the final destination, including a visualindication of where to penetrate through the wall of the body organ, tothe ROI.

The endoscope of the present invention also contemplates a method ofcollecting and/or sampling body fluids. A body fluid collection devicedisclosed in U.S. Pat. No. 9,713,461 comprises a longitudinal memberhaving a lumen formed along a longitudinal axis and configured to beinserted through a conduit and/or channel, a flow path in which asuction is acted by the suction section of the endoscope, which isformed to bring the lumen of the longitudinal member in communicationwith the conduit and/or channel, an accommodating section which isformed in the flow path, and accumulate the body fluid suctioned in thelumen by the suction section of the endoscope, and a sealing memberconfigured to seal a space between the longitudinal member and thechannel closer to a distal end of the longitudinal member than thesuction port so that a fluid does not flow from the distal end side to aproximal end side of the longitudinal member.

A body fluid collection device configured to be used in combination withan endoscope having a channel and a suction section configured tosuction the inside of the channel from a suction port in communicationwith the conduit and/or channel, the body fluid collection devicecomprises a longitudinal member having a lumen formed along alongitudinal axis and configured to be inserted through the channel, aflow path in which a suction is acted by the suction section of theendoscope, which is formed to bring the lumen of the longitudinal memberin communication with the channel, an accommodating section which isformed in the flow path, and accumulate the body fluid suctioned in thelumen by the suction section of the endoscope, and a sealing memberconfigured to seal a space between the longitudinal member and thechannel closer to a distal end of the longitudinal member than thesuction port so that a fluid does not flow from the distal end side to aproximal end side of the longitudinal member.

The endoscope of the present invention may be involved in evaluatingdisease, normal tissues, pharynx/larynx/esophagus/stomach/smallintestine as well as disease diagnosis and management of airways (suchas but not limited to trachea and bronchi) including endoscopicprocedures (such as but not limited to biopsy, balloon dilation andlavage).

A method and system for diagnosing and treating infection or disease, inwhich an individual takes a photograph of an infected or diseased areaof a body using a camera connected to a microprocessor disclosed in U.S.Pat. No. 9,649,013 is contemplated. A photograph may be sent to adiagnosing center having a server with a second microprocessor and adatabase of photographs correlated with different diseases andinfections. The second microprocessor scans the image received from thecamera and compares it to the photographs in the database. If a match isfound, the second microprocessor then notes the disease or bacteriacorresponding to the matching photograph. The second microprocessor thensearches an additional database correlated to the match, to furtherrefine the diagnosis. The second microprocessor then searches the seconddatabase for a treatment corresponding to the identified disease orbacteria. Once a treatment is identified, information regarding thistreatment is automatically sent to the individual's microprocessor.

The endoscope of the present invention may have a shaft connected to acamera, which can record video and still images seen through shaft. Thevideo and still images may be transmitted to a microprocessor via acable. The video and still images can also be displayed on a displayscreen. A microprocessor may be connected to a communication device,which can be a modem. The images obtained by a camera may be compared toan initial database stored inside a database connected tomicroprocessor, and if a match is found, then sent to a second database,accessible over the internet, for a more refined diagnosis. Once thefinal diagnosis has been made, the diagnosis and possible treatments aresent back to the physician, and can be displayed on a display, or can becommunicated in another manner, such as by voice instructions orholographically onto an eyepiece or lenses worn by the physician duringthe procedure, so that the physician does not have to look away from theprocedure to receive the diagnosis. The holographic message could alsobe projected onto a lens of a microscope, or the endoscope, or even ontoa wall or other surface.

The endoscope may have an extension attached to its distal end. In use,an extension can be inserted into the tissue of a patient so that alayer of cells lies on top of the top surface of the extension. Thislayer can then be illuminated, either from behind, if the extension istranslucent, or from the front, by the light source of the endoscope.The layer can be the thickness of a single layer of cells. Thus, thecamera takes an image that is essentially a prepared slide for sendingto a microprocessor. Thus, the cells of the tissue being examined aremore visible and the diagnosis can be made more easily. This procedurealso saves the time and expense required in preparation of slides in alaboratory.

A non-invasive and minimally invasive denervation methods and systemsfor performing the same as disclosed in U.S. Pat. No. 9,649,154 is alsocontemplated for the present invention. A system and method can be usedto denervate at least a portion of a bronchial tree. An energy emitterof an instrument is percutaneously delivered to a treatment site andoutputs energy to damage nerve tissue of the bronchial tree. Thedenervation procedure can be performed without damaging non-targetedtissue. Minimally invasive methods can be used to open airways toimprove lung function in subjects with COPD, asthma, or the like.Different sections of the bronchial tree can be denervated while leavingairways intact to reduce recovery times.

A minimally invasive system capable of treating the respiratory systemto enhance lung function may be utilized to treat a subject sufferingfrom COPD, asthma, or the like and, thus, the lungs may perform poorly.To decrease air flow resistance to increase gas exchange, the system canbe used to perform a denervation procedure.

The instrument can be used to attenuate the transmission of signalstraveling along the vagus nerves that cause or mediate musclecontractions, mucus production, inflammation, edema, and the like.Attenuation can include, without limitation, hindering, limiting,blocking, and/or interrupting the transmission of signals. For example,the attenuation can include decreasing signal amplitude of nerve signalsor weakening the transmission of nerve signals. Decreasing or stoppingnervous system input to distal airways can alter airway smooth muscletone, airway mucus production, airway inflammation, and the like,thereby controlling airflow into and out of the lungs. Decreasing orstopping sensory input from the airways and lungs to local effectorcells or to the central nervous system can also decrease reflexbronchoconstriction, reflex mucous production, release of inflammatorymediators, and nervous system input to other cells in the lungs ororgans in the body that may cause airway wall edema. In someembodiments, the nervous system input can be decreased tocorrespondingly decrease airway smooth muscle tone. In some embodiments,the airway mucus production can be decreased a sufficient amount tocause a substantial decrease in coughing and/or in airflow resistance.In some embodiments, the airway inflammation can be decreased asufficient amount to cause a substantial decrease in airflow resistanceand ongoing inflammatory injury to the airway wall. Signal attenuationmay allow the smooth muscles to relax, prevent, limit, or substantiallyeliminate mucus production by mucous producing cells, and decreaseinflammation. In this manner, healthy and/or diseased airways can bealtered to adjust lung function. After treatment, various types ofquestionnaires or tests can be used to assess the subject's response tothe treatment. If needed or desired, additional procedures can beperformed to reduce the frequency of coughing, decrease breathlessness,decrease wheezing, and the like.

Main bronchi (i.e., airway generation) can be treated to affect distalportions of the bronchial tree. In some embodiments, the left and rightmain bronchi are treated at locations along the left and right lungroots and outside of the left and right lungs. Treatment sites can bedistal to where vagus nerve branches connect to the trachea and the mainbronchi and proximal to the lungs. A single treatment session involvingtwo therapy applications can be used to treat most of or the entirebronchial tree. Substantially all of the bronchial branches extendinginto the lungs may be affected to provide a high level of therapeuticeffectiveness. Because the bronchial arteries in the main bronchi haverelatively large diameters and high heat sinking capacities, thebronchial arteries may be protected from unintended damage due to thetreatment.

Nerve tissue distal to the main bronchi can also be treated, such asnerve tissue positioned outside the lung which run along the right orleft main bronchi, the lobar bronchii, and bronchus intermedius. Theintermediate bronchus is formed by a portion of the right main bronchusand includes origin of the middle and lower lobar bronchii. The distalsection can be positioned alongside higher generation airways (e.g.,airway generations >2) to affect remote distal portions of the bronchialtree. Different procedures can be performed to denervate a portion of alobe, an entire lobe, multiple lobes, or one lung or both lungs. In someembodiments, the lobar bronchi are treated to denervate lung lobes. Forexample, one or more treatment sites along a lobar bronchus may betargeted to denervate an entire lobe connected to that lobar bronchus.Left lobar bronchi can be treated to affect the left superior lobeand/or the left inferior lobe. Right lobar bronchi can be treated toaffect the right superior lobe, the right middle lobe, and/or the rightinferior lobe. Lobes can be treated concurrently or sequentially. Insome embodiments, a physician can treat one lobe. Based on theeffectiveness of the treatment, the physician can concurrently orsequentially treat additional lobe(s). In this manner, differentisolated regions of the bronchial tree can be treated.

Each segmental bronchus may be treated by delivering energy to a singletreatment site along each segmental bronchus. Nerve tissue of eachsegmental bronchus of the right lung can be destroyed. In someprocedures, one to ten applications of energy can treat most of orsubstantially all of the right lung. Depending on the anatomicalstructure of the bronchial tree, segmental bronchi can often bedenervated using one or two applications of energy.

Function of other tissue or anatomical features, such as the mucousglands, cilia, smooth muscle, body vessels (e.g., blood vessels), andthe like can be maintained when nerve tissue is ablated. Nerve tissueincludes nerve cells, nerve fibers, dendrites, and supporting tissue,such as neuroglia. Nerve cells transmit electrical impulses, and nervefibers are prolonged axons that conduct the impulses. The electricalimpulses are converted to chemical signals to communicate with effectorcells or other nerve cells. By way of example, a portion of an airway ofthe bronchial tree can be denervated to attenuate one or more nervoussystem signals transmitted by nerve tissue. Denervating can includedamaging all of the nerve tissue of a section of a nerve trunk along anairway to stop substantially all the signals from traveling through thedamaged section of the nerve trunk to more distal locations along thebronchial tree or from the bronchial tree more proximally to the centralnervous system. Additionally, signals that travel along nerve fibersthat go directly from sensory receptors (e.g., cough and irritantreceptors) in the airway to nearby effector cells (e.g., postganglionicnerve cells, smooth muscle cells, mucous cells, inflammatory cells, andvascular cells) will also be stopped. If a plurality of nerve trunksextends along the airway, each nerve trunk can be damaged. As such, thenerve supply along a section of the bronchial tree can be cut off. Whenthe signals are cut off, the distal airway smooth muscle can relaxleading to airway dilation, mucous cells decrease mucous production, orinflammatory cells stop producing airway wall swelling and edema. Thesechanges reduce airflow resistance so as to increase gas exchange in thelungs, thereby reducing, limiting, or substantially eliminating one ormore symptoms, such as breathlessness, wheezing, chest tightness, andthe like. Tissue surrounding or adjacent to the targeted nerve tissuemay be affected but not permanently damaged. In some embodiments, forexample, the bronchial blood vessels along the treated airway candeliver a similar amount of blood to bronchial wall tissues and thepulmonary blood vessels along the treated airway can deliver a similaramount of blood to the alveolar sacs at the distal regions of thebronchial tree before and after treatment. These blood vessels cancontinue to transport blood to maintain sufficient gas exchange. In someembodiments, airway smooth muscle is not damaged to a significantextent. For example, a relatively small section of smooth muscle in anairway wall which does not appreciably impact respiratory function maybe reversibly altered. If energy is used to destroy the nerve tissueoutside of the airways, a therapeutically effective amount of energydoes not reach a significant portion of the non-targeted smooth muscletissue.

Any number of procedures can be performed on one or more of these nervetrunks to affect the portion of the lung associated with those nervetrunks. Because some of the nerve tissue in the network of nerve trunkscoalesces into other nerves (e.g., nerves connected to the esophagus,nerves though the chest and into the abdomen, and the like), specificsites can be treated to minimize, limit, or substantially eliminateunwanted damage of other nerves. Some fibers of anterior and posteriorpulmonary plexuses coalesce into small nerve trunks which extend alongthe outer surfaces of the trachea and the branching bronchi andbronchioles as they travel outward into the lungs. Along the branchingbronchi, these small nerve trunks continually ramify with each other andsend fibers into the walls of the airways.

An activatable element in the form of an energy emitter is configured todamage nerve tissue, such as a vagus nerve branch. Vagus nerve tissueincludes efferent fibers and afferent fibers oriented parallel to oneanother within a nerve branch. The efferent nerve tissue transmitssignals from the brain to airway effector cells, mostly airway smoothmuscle cells and mucus producing cells. The afferent nerve tissuetransmits signals from airway sensory receptors, which respond toirritants, and stretch to the brain. There is a constant, baseline tonicactivity of the efferent vagus nerve tissues to the airways which causesa baseline level of smooth muscle contraction and mucous secretion.

The energy emitter can ablate the efferent and/or the afferent tissuesto control airway smooth muscle (e.g., innervate smooth muscle), mucoussecretion, nervous mediated inflammation, and tissue fluid content(e.g., edema). The contraction of airway smooth muscle, excess mucoussecretion, inflammation, and wall edema associated with pulmonarydiseases often results in relatively high air flow resistance causingreduced gas exchange and decreased lung performance.

The instrument can be delivered through a percutaneous opening in thechest, back, or other suitable location. Potential access locationsinclude between the ribs in the chest, between the ribs in apara-sternal location, between the ribs along the back or side of thesubject, from a subxiphoid location in the chest, or through thepre-sternal notch superior to the manubrium. As used herein, the term“percutaneous” and derivations thereof refer generally to medicalprocedures that involve accessing internal organs via an opening, suchas a puncture or small incision in a subject's skin and may involve theuse of an access apparatus, such as the access apparatus. The accessapparatus can be in the form of a trocar, a cannula, a port, a sleeve,or other less-invasive access device, along with an endoscope. Thedistal section can be relatively sharp to puncture and pass throughtissue. A stylet can be positioned in a lumen in the instrument and canhave a relatively sharp tip to directly puncture the skin. After thestylet is inserted into the skin, the instrument can be moved along thestylet through the user's skin into and between internal organs.

The instrument may be visualized using fluoroscopy, computed tomography(CT), thoracoscopy, ultrasound, or other imaging modalities, and mayhave one or more markers (e.g., radiopaque marks), or dyes (e.g.,radiopaque dyes), or other visual features. The visual features can helpincrease the instrument's visibility, including the instrument'sradiopacity or ultrasonic visibility.

An instrument shaft can be made of a generally flexible material toallow delivery along tortuous paths to remote and deep sites. The distalsection can be steered or otherwise manipulated using a steeringassembly. The distal section can be deflected laterally or shaped into adesired configuration to allow enhanced navigation around thoracicstructures. To deliver energy to a treatment site, the distal sectioncan assume a treatment configuration. The treatment configuration can bea serpentine configuration, a helical configuration, a spiralconfiguration, a straight configuration, or the like. Conventionalelectrode catheters or ablation catheters can also be used to perform atleast some methods disclosed herein.

As used herein, the term “energy” is broadly construed to include,without limitation, thermal energy, cryogenic energy (e.g., coolingenergy), electrical energy, acoustic energy (e.g., ultrasonic energy),microwave energy, radiofrequency energy, high voltage energy, mechanicalenergy, ionizing radiation, optical energy (e.g., light energy), andcombinations thereof, as well as other types of energy suitable fortreating tissue. The energy emitter 209 of FIG. 3 can include one ormore electrodes (e.g., needle electrodes, bipolar electrodes, ormonopolar electrodes) for outputting energy, such as ultrasound energy,radiofrequency (RF) energy, radiation, or the like. The electrodes canoutput a sufficient amount of RF energy to form a lesion at theperiphery of the airway. To avoid damaging smooth muscle tissue, alesion can have a depth less than or equal to about 2 mm. In someembodiments, the lesion depth D can be less than about 1 mm to localizetissue damage. Thermal energy emitters can be resistive heaters orthermally conducting elements. To treat tissue with microwave energy,the energy emitter can include one or more microwave antennas. Inoptical embodiments, the energy emitter includes one or more lenses orreflector(s) capable of outputting light delivered via one or moreoptical fibers. An external light source (e.g., a lamp, an array oflight emitting diodes, or the like) can output light that is deliveredthrough the shaft to the energy emitter. In other embodiments, theenergy emitter is a light source, such as a light-emitting diode (LED)or laser diode. Photodynamic agents or light activatable agents can beused to ablate tissue. In yet other embodiments, the energy emitter caninclude a dispenser (e.g., a nozzle, an orifice, etc.) for delivering asubstance (e.g., a chemical agent, a high temperature fluid, a cuttingjet, etc.) that kills or damages targeted tissue. Multiple emitters canbe used sequentially or simultaneously to treat tissue. For example, anenergy emitter in the form of a dispenser can mechanically damagesurface tissue while another energy emitter outputs radiofrequency ormicrowave energy to destroy deep tissue.

For mechanical denervation, the distal section can mechanically damagetissue by cutting, abrading, or tearing nerve tissue. A minimal amountof tissue adjacent to the nerve tissue 45 may also be damaged. Thedamaged non-targeted tissue can heal without any appreciable decrease inlung function. In embodiments, the distal section comprises amorcellation device.

The distal section can comprise one or more energy absorption devicesfor absorbing energy from a remote energy source. The remote energysource can be a microwave energy source, a radiofrequency energy source,an ultrasound energy source, or a radiation energy source and can bepositioned outside the subject's body or located in another bodystructure, such as the esophagus, airway (trachea or bronchus), orelsewhere in the subject's body. The distal section can be heated by theremote energy source to a sufficient temperature to damage targetedtissue. Additionally or alternatively, the element can include areflector to reflect energy from a remote energy source. The reflectedenergy can create a pattern (e.g., interference pattern) to control theamplitude of energy waves at the target site.

The controller can include one or more processors, microprocessors,digital signal processors (DSPs), field programmable gate arrays (FPGA),and/or application-specific integrated circuits (ASICs), memory devices,buses, power sources, and the like. For example, the controller caninclude a processor in communication with one or more memory devices.Buses can link an internal or external power supply to the processor.The memories may take a variety of forms, including, for example, one ormore buffers, registers, random access memories (RAMs), and/or read onlymemories (ROMs). The controller may also include a display, such as ascreen, and can be a closed loop system, whereby the power to the distalsection s controlled based upon feedback signals from one or moresensors configured to transmit (or send) one or more signals indicativeof one or more tissue characteristics, energy distribution, tissuetemperature, or any other measurable parameters of interest. Based onthose readings, the controller can then adjust operation of the distalsection. By way of example, the controller can control the amount ofenergy delivered from the energy source (e.g., one or more batteries orother energy storage devices) to the energy emitter. The sensor can be atemperature sensor. If the temperature of the peripheral tissue of theairway becomes too hot, the distal section can cool the tissue using oneor more Peltier devices, cooling balloons, or other types of coolingfeatures. Current sensors or voltage sensors can be used to measure thetissue impedance. Alternatively, the controller can be an open loopsystem wherein the operation is set by user input. For example, thesystem may be set to a fixed power mode. It is contemplated that thesystem can be repeatedly switched between a closed loop mode and an openloop mode to treat different types of sites.

The instrument can also include any number of different types ofvisualization devices, such as cameras, optical fibers, lenses, ormirrors. Ultrasound or other types of energy-based viewing systems canbe used to visualize deep targeted tissues. Surface tissues can betargeted using direct visualization while deeper tissues aresubsequently targeted using ultrasound.

As used herein, the term “ablate,” including variations thereof, refers,without limitation, to destroying or permanently damaging, injuring, ortraumatizing tissue. For example, ablation may include localized tissuedestruction, cell lysis, cell size reduction, necrosis, or combinationsthereof. In the context of pulmonary ablation applications, the term“ablation” includes sufficiently altering nerve tissue properties tosubstantially block transmission of electrical signals through theablated nerve tissue. Ablating all of the nerve trunks along the airwayprevents nerve signals from traveling distally along the airway andcauses the smooth muscle to relax to open the airway.

In RF ablation, RF energy causes heating of the nerve tissue and,ultimately, the formation of the lesion. The nerve tissue is destroyedwithout removing a significant amount of airway tissue, if any, topreserve the integrity of the airway. The lesion can be left in the bodyto avoid potential complications from removing airway tissue. Thehealthy airway wall prevents gas escape across the airway wall. Thesmooth muscle and interior lining of the airway can remain substantiallyundamaged to allow mucociliary transport and other bodily functions thatare important to overall health. This reduces the recovery time andavoids or mitigates problems associated with surgical techniques ofremoving or cutting through the airway wall. In contrast to lungresection procedures in which entire airways are severed and removed, anintact denervated airway can also ensure that distal regions of the lungcontinue to function.

Large lesions can extend through the airway wall and can be formed todestroy unwanted tissue (e.g., cancerous tissues) positioned along theinner surface. Differential cooling can be used to form lesions burieddeep within the sidewall, spaced apart from the interior and exteriorsurfaces of the airway, or any other suitable location. The instrumentcan cool tissues to keep the nontargeted tissue below a temperature atwhich cell death occurs. In some embodiments, the distal section has acooling member (e.g., a cooling balloon) that absorbs thermal energy tokeep nontargeted regions of the airway wall at or below a desiredtemperature. The shape and size of lesions can also be adjusted asdesired.

Natural body functions can help prevent, reduce, or limit tissue damage.If the bronchial artery branch is heated, blood within the blood vesselscan absorb the thermal energy and can then carry the thermal energy awayfrom the heated section of the branches. The lesion can surround aregion of the blood vessel 130 without destroying the vessel. After thetreatment is performed, the bronchial artery branches can continue tomaintain the health of lung tissue.

The lesion depth can be kept at or below a desired depth by controllingthe amount of delivered energy. To avoid reaching smooth muscle, thedepth can be equal to or less than about 3 mm, 2 mm, or 1 mm. For thickairway walls, the lesion depth can be equal to or less than about 3 mm.For medium size airway walls, the lesion depth can be equal to or lessthan about 2 mm. In young children with thin airway walls, the lesiondepth can be equal to or less than about 1 mm. The lateral dimensions(e.g., width, length, etc.) of the lesion can be adjusted to ensure thattargeted tissue is ablated.

The instrument can be delivered along the trachea, esophagus, pharynx,or other body structure in the vicinity of the treatment site. Forexample, the instrument can extend through one or more organs toposition an energy emitter 314 proximate to the targeted tissue. Theinstrument can cool interior regions of the airway wall to cause theformation of the lesion at the outer periphery of the airway wall. Forradiofrequency ablation, the RF energy can travel between bipolarelectrodes. Tissue impedance causes heating that can reach sufficientlyhigh temperatures to cause cell death. To protect non-targeted tissues(e.g., interior tissue), the instrument can cool the airway to keep thenontargeted tissue below a temperature at which cell death occurs.

Thermal energy can be absorbed by the instrument to keep the exteriorregions of the airway wall at or below a desired temperature. Bothinstruments can provide cooling to form lesions generally midway throughthe airway wall. The amount of energy delivered and cooling capacityprovided by the instruments can be adjusted to shape and form lesions atdifferent locations.

At least one of the instruments can be adapted to tunnel through tissueor between adjacent structures to allow it to reach the desiredlocation, for example, along the bronchi. Additionally or alternatively,the instruments may be adapted to adhere to or slide smoothly alongtissue or to be urged against a structure (e.g., trachea, esophagus,and/or bronchi) as the instrument is advanced.

A wide range of different types of guides can partially or completelysurround a structure, such as the esophagus, trachea, or bronchus.Guides may include, without limitation, a plurality of arms (e.g., apair of arms, a set of curved or straight arms, or the like), a ring(e.g., a split ring or a continuous ring), or the like.

Cartilage rings or cartilage layers typically have a significantlylarger electrical resistance than airway soft tissue (e.g., smoothmuscle or connective tissue). Airway cartilage can impede the energyflow (e.g., electrical radiofrequency current flow) and makes theformation of therapeutic lesions to affect airway trunks challengingwhen the electrode is next to cartilage. The electrodes can bepositioned to avoid energy flow through cartilage. For example, theelectrode can be positioned between cartilage rings. Most orsubstantially all of the outputted energy can be delivered between therings in some procedures. Tissue impedance can be measured to determinewhether a particular electrode is positioned next to a cartilage ring,in an intercartilaginous space, or at another location.

The instrument may have a lumen to receive a stylet to straighten andstiffen the preshaped distal section during introduction. Afterinsertion, the stylet can be withdrawn to allow the preshaped distalsection to assume a treatment configuration (e.g., a spiralconfiguration, a helical configuration, or the like). Alternatively, thedistal section may be relatively flexible and straight duringintroduction. A stylet having a shape corresponding to a desired shapemay be inserted into the instrument to impart the desired shape to thedistal section. In a further embodiment, the instrument may be shapeableor steerable using an actuator at its proximal end to allow it to besteered so as to surround the target tubular structure. Various steeringmechanisms can be used, including, for example, one or more pull wiresanchored to a distal tip at a point offset from the center line. Thewire(s) can extend slidably through one or more lumens in the instrumentto the proximal end where they may be tensioned by an actuator so as todeflect the distal section.

A system for non-invasively denervating a bronchial tree may include anexternal energy source connected to an energy delivery system. Theexternal energy source can emit a beam of radiation to targeted tissue,such as nerve tissue. The beam of radiation can destroy the targetedtissue. The system can include, or be in the form of, a CyberKnife®Robotic Radiosurgery System from Accuray®, a TomoTherapy® radiationtherapy system, or similar type of systems capable of targeting movingtissue, thereby mitigating or limiting damage to non-targeted tissue.

Beam radiation may be delivered from different remote locations todamage deep nerve tissue without damaging intervening tissues. Thesource of beam radiation may be a beam emitter of an external beamradiotherapy system or a stereotactic radiation system. Because thelungs and bronchi move as the subject breathes, the system can beadapted to target moving tissues. By positioning the radiation beamemitter at various locations relative to the patient's body, suchsystems may be used to deliver a radiation beam from various angles tothe targeted nerve tissue. The dose of radiation given to interveningtissues may be insufficient to cause injury, but the total dose given tothe target nerve tissue is high enough to damage (e.g., ablate) thetargeted tissue.

Ultrasound can be used to damage targeted tissue. High intensity focusedultrasound may be used to target and damage the nerve tissue. Theexternal energy source can be a HIFU emission device. Alternatively, acatheter, an intra-luminal instrument, or other type of instrument forinsertion into the body can include a HIFU emission device. Suchembodiments are well suited for delivery through another body structure,such as the esophagus or airway, to treat target tissue of an airway.The HIFU instrument may include ultrasound imaging capability to locatethe targeted tissues. The HIFU instrument can emit a plurality ofultrasound “beams” from different angles toward the target tissues. Theintensity of any one of the beams can be insufficient to damageintervening tissues. The beams can interfere at the target site andtogether have sufficient magnitude to damage the target nerve tissue.

The HIFU-based systems can be adapted to target moving tissues. Forexample, such systems may have a computer-controlled positioning systemwhich receives input from an ultrasound or other imaging system andcommands a positioning system in real time to maintain the HIFU devicein a fixed position relative to the target structure.

Instruments disclosed herein may be entirely or partially controlledrobotically or by a computer. Instruments may be attachable to acomputer-controlled robotic manipulator which moves and steers theinstruments. Robotic systems, such as the da Vinci® Surgical System fromIntuitive Surgical or the Sensei Robotic Catheter system from HansenMedical, Inc., or similar types of robotic systems, can be used. Theinstruments can have a proximal connector (e.g., an adaptor mechanism)that connects with a complementary fitting on the robotic system andlinks movable mechanisms of the instrument with control mechanisms inthe robotic system. The instrument connector can also provide electricalcouplings for wires leading to energy emitters, electrodes, microwaveantennae, or other electrically powered devices. The instrument mayfurther include sensor devices (e.g., temperature sensors, tissueimpedance sensors, etc.) which are also coupled via the connector of therobotic system. The robotic system can include a control module thatallows the physician to move and activate the denervation instrumentwhile visualizing the location of the instrument within the chest, forexample, using thoracoscopy, fluoroscopy, ultrasound, or other suitablevisualization technology. The instrument may also be computercontrolled, with or without robotic manipulation. A computer may receivefeedback (e.g., sensory data) from sensors carried by the instrument orelsewhere to control positioning, power delivery, or other parameters ofinterest. For example, in energy-based denervation embodiments, acomputer may be used to receive temperature data from temperaturesensors of the instrument and to control power delivery to avoidoverheating of tissue.

The instruments can access sites through blood vessels, as well asexternal to the organs. Robot surgery (including robotic cathetersystems), natural orifice access methods, and minimally invasive accessmethods such as using trocar access methods and thoracoscopy haveprovided clinicians with access procedure locations within the humanbody and also minimized patient morbidity and complications due tosurgery.

The assemblies, methods, and systems described herein can be used toaffect tissue which is located on the outside of hollow organs, such asthe lung, esophagus, nasal cavity, sinus, colon, vascular vessels andthe like or other solid organs. Various types of activatable elements(e.g., energy emitters) can be utilized to output the energy. Theactivatable elements can be sufficiently small to facilitatepercutaneous delivery to minimize or limit trauma to the patient.

The embodiments disclosed herein can treat the digestive system, nervoussystem, vascular system, or other systems. The treatment systems and itscomponents disclosed herein can be used as an adjunct during anothermedical procedure, such as minimally invasive procedures, openprocedures, semi-open procedures, or other surgical procedures (e.g.,lung volume reduction surgery) that provide access to a desired targetsite. Various surgical procedures on the chest may provide access tolung tissue, the bronchial tree, or the like. Access techniques andprocedures used to provide access to a target region can be performed bya surgeon and/or a robotic system. Those skilled in the art recognizethat there are many different ways that a target region can be accessed.

The present invention also contemplates accessory devices which may beinvolved, for example but not limited to, cessation of bleeding/cauteryor removal of a foreign body. An accessory device is disclosed in U.S.Pat. No. 8,007,432 and can include an insertion member and a controlwire. The insertion member can have a lumen for receiving a tooltherethrough, such as an endoscope. The control wire can be coupled tothe insertion member and have a distal portion extending distally fromthe insertion member and be adapted to receive and to manipulate a toolextending through the insertion member. The control wire can have a widevariety of configurations, and in certain exemplary embodiments thecontrol wire can be slidably received in one or more control wire lumensformed through the insertion member. In use, the control wire can bemanipulated, for example by axially sliding the control wire in one ormore control wire lumens to control a tool.

The accessory device can have a variety of configurations, but in theillustrated embodiment the accessory device includes an insertion memberin the form of an elongate sheath and an accessory channel. As shown,the elongate sheath can have a distal end with a control wire coupledthereto and a proximal end with a handle and a control mechanism coupledthereto. The elongate sheath can have an endoscope disposedtherethrough. The distal face of the endoscope can have a viewinginstrument, for example a lens, one or more lighting elements, forexample lights or fiber optics, and a lumen formed therein for receivingone or more tools, such as viewing instruments, graspers, cuttingdevices, irrigation devices, and so on. The elongate sheath can alsohave a mating element such as a track for mating with a complementarymating element formed on the accessory channel, such as a rail. Inaddition, the elongate sheath can have one or more control wire lumensformed therein and extending between the proximal and distal endsthereof. The control wire can be slidably disposed in the control wirelumens. The control mechanism can be coupled to the control wire and canbe adapted to move the control wire, for example, by manipulation of aknob. Movement of the control wire can include, for example, axiallysliding the control wire within one or both of the control wire lumensor axially rotating the control wire. In use, movement of the controlwire can be effective to manipulate a tool. The tool, for example, canextend distally from the lumen in the endoscope, or from the accessorychannel, or the tool can be separate from or spaced apart from theelongate sheath. The manipulation can take many forms, but as oneexample, a portion of the tool can be pulled into a viewing window ofthe endoscope.

As one skilled in the art will understand, the accessory device need notinclude an accessory channel. For example, the insertion member can bein the form of an elongate sheath with a control wire coupled thereto.In such a case, the elongate sheath need not include a mating elementsuch as a track adapted for mating to the accessory channel. In use,movement of the control wire can be effective to manipulate a toolextending distally from a lumen formed in an endoscope, such as thelumen in the endoscope. Further, one skilled in the art will alsounderstand that it is not necessary to include an elongate sheath or anaccessory channel. For example, an alternate embodiment of an accessorydevice can have an insertion member in the form of an endoscope. Asshown, a lumen is formed in the endoscope for receiving a tooltherethrough and the distal end of the endoscope has a viewing elementand a first and second lighting elements. The endoscope may have a firstand second control wire lumens formed therein. In use, the control wirecan be moved to manipulate a tool extending distally from the lumenand/or a tool adjacent to the accessory device, such as another tooldisposed at the surgical site.

The accessory device, as well as any other exemplary accessory devicespreviously described, can have a variety of other configurations, as oneskilled in the art will understand. For example, the accessory devicecan have multiple accessory channels, lumens for receiving tools, and/orelongate sheaths. On the other hand, the accessory device need notreceive a tool, and instead the control wire can be adapted tomanipulate a tool inserted separately to the surgical site within thebody. Any of the previously described lumens, such as an accessorychannel lumen and/or endoscope lumen, can receive surgical materials,irrigating fluids, antiseptic agents, or organic substances, etc.,therethrough in addition to or instead of tools. The accessory devicecan have multiple control wires which can be movable within control wirelumens and/or fixedly attached to the accessory device. The controlwires can be arranged to provide multiple loops or arcs at the distalend of the accessory device, and/or can be arranged in a fashion similarto that of a single control wire. In some embodiments, control wirelumens can be associated with the accessory channel instead of or inadditional to elongate sheath. A wide array of further variations willbe apparent to those skilled in the art.

The present invention also provides methods for manipulating a tool. Inone exemplary method, an accessory device such as the accessory devicecan be positioned at a surgical site. The accessory device can bepositioned in the body by inserting the distal end of the accessorydevice into a natural orifice such as the mouth, or through an incisionmade in the body. The accessory device can be advanced distally througha body lumen to a desired position. The insertion may be associated withor preceded by any number of procedures to lubricate, flex, shape,measure, steer, turn, rotate, and/or guide the accessory device into thebody. The insertion may also be assisted by or performed with a viewinginstrument such as an endoscope for showing the path of the accessorydevice within the body.

In other embodiments, inserting the accessory device can includeinserting an endoscope through an elongate sheath, and mating anaccessory channel to an elongate sheath. For example, the rail of theaccessory channel can be slidably mated to the track of the elongatesheath, and the accessory channel can be advanced to a desired positionalong the elongate sheath. Such mating can be performed at any time,including before and after part of the accessory device is inserted inthe body. After it is mated, the accessory channel can be unmated, e.g.,by sliding the accessory channel proximally along the elongate shaft,and re-mated any number of times to re-introduce the accessory channelor to introduce other accessory channels.

Surgical tools as well as materials can be inserted through one or morelumens in the accessory device. For example, a tool can be insertedthrough the elongate sheath, through a lumen formed in an endoscopedisposed in the elongate sheath, and/or through the accessory channel.Multiple tools can be inserted through a single lumen or throughseparate lumens. Moreover, as will be apparent to those skilled in theart, a tool can also be inserted into the body separately from theaccessory device, for example, not through any lumen formed therein. Atool can be advanced beyond the distal end of the elongate sheath andcan be positioned, articulated, and maneuvered at the surgical site, asmay be called for by a surgical procedure.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces, and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning and/or replacement, and reassembly. Use of such techniques, andthe resulting reconditioned device, are all within the scope of thepresent application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used tool is obtained and if necessary cleaned.The tool can then be sterilized. In one sterilization technique, thetool is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and tool are then placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation kills bacteria on theinstrument and in the container. The sterilized instrument can then bestored in the sterile container. The sealed container keeps theinstrument sterile until it is opened in the medical facility. It ispreferred that the device is sterilized. This can be done by any numberof ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, or steam.

The invention also contemplates the use of the herein disclosedendoscope to study the gastrointestinal (GI) tract, in particularvisualization of the GI tract contents and abnormalities as well asmeasurement of the GI tract. A medical system disclosed in U.S. Pat. No.9,675,526 for facilitating installation of a PEG device in a patient'sbody by utilizing an endoscope is contemplated. Such a system comprisesa needle configured to be disposed within an endoscope lumen of theendoscope and moveable along a longitudinal axis relative to theendoscope, wherein the needle includes a needle lumen extendingtherethrough; a safety cap for being placed on the outside of thepatient's body, the safety cap having a cap lumen extendinglongitudinally therethrough, the cap lumen sized and configured toreceive and secure the needle such that the needle lumen and cap lumenare in fluid communication, the cap lumen sized and structured tofrictionally engage the needle to secure the needle to the safety cap;and a wire sized and configured to extend completely through the caplumen and through at least a portion of the needle lumen.

The endoscope is generally flexible while retaining sufficient rigidityto allow it to be pushed through a patient's body toward the targetsite. The type of endoscope may be configured to extend through apatient's mouth, the upper GI tract, and out through a hole in thepatient's abdomen. The length of the endoscope may be approximately 160cm; however, other lengths could also be used that are long enough toextend out of the mouth, through the upper GI tract, and through thepatient's abdomen. Thus, it will appreciated that various lengths couldapply to patient's having various body sizes. Known percutaneousendoscopic gastrostomy devices capable of being pulled through the GItract by a wire having a looped end can also be used. Additionally,other tube-like devices for extending through tissue can also be used,including PEG devices and other devices that can be pushed through theupper GI tract over a guidewire.

The present invention also contemplates injection of medication via theendoscope of the present invention, preferably with a medical fluiddevice. Typical of medical fluid devices is a vascular access devicethat allows for the introduction of medication, antibiotics,chemotherapeutic agents, or a myriad of other fluids, to a previouslyestablished IV fluid flow system. Alternatively, the access device maybe used for withdrawing fluid from the subject for testing or otherpurposes. The presence of one or more access devices in the IV tubingsets eliminates the need for phlebotomizing the subject repeatedly andallows for immediate administration of medication or other fluidsdirectly into the subject.

Several different types of access devices are well known in the medicalfield. Although varying in the details of their construction, thesedevices usually include an access site for introduction or withdrawal ofmedical fluids through the access device. For instance, such devices caninclude a housing that defines an access opening for the introduction orwithdrawal of medical fluids through the housing, and a resilient valvemember or gland that normally closes the access site. Beyond thosecommon features, the design of access sites varies considerably. Forexample, the valve member may be a solid rubber or latex septum or bemade of other elastomeric material that is pierceable by a needle, sothat fluid can be injected into or withdrawn from the access device.Alternatively, the valve member may comprise a septum or the like with apreformed but normally closed aperture or slit that is adapted toreceive a specially designed blunt cannula therethrough. Other types ofaccess devices are designed for use with connecting apparatus employingstandard male luers. Such an access device is commonly referred to as a“luer access device” or “luer-activated device,” or “LAD.” LADS ofvarious forms or designs are illustrated in U.S. Pat. Nos. 6,682,509,6,669,681, 6,039,302, 5,782,816, 5,730,418, 5,360,413, and 5,242,432.

The present invention also contemplates use of the endoscope for abiopsy. In particular, an additional biopsy needle attached to theendoscope of the present invention is contemplated. A biopsy needlehaving a longitudinal channel formed within an inner conductor of acoaxial antenna is disclosed in U.S. Pat. No. 9,351,713. The coaxialantenna terminates in a rigid insertion tip e.g. a ceramic cone that isinsertable into biological tissue. Microwave energy (e.g. having afrequency of 1 to 100 GHz) delivered to the coaxial antenna is emittedat the insertion tip. The insertion tip may be arranged to match theimpedance of the coaxial antenna to a predetermined tissue impedance.The emitted radiation can be used to measure properties of or treat(e.g., ablate) tissue at the insertion tip. Needle biopsy apparatus isalso disclosed, in which a microwave energy is controllably delivered toa needle from a microwave generator. The apparatus may include animpedance tuner to dynamically match the impedance of the needle withtissue at the insertion tip.

According to one aspect of the invention, there may be provided a biopsyneedle insertable into tissue for introducing or extracting a sampletherefrom, the needle having an elongate body terminating with aninsertion tip, a longitudinal channel formed within the body fortransporting the sample, and a coaxial antenna comprising an innerconductor and an outer conductor coaxial with the inner conductor andseparated from it by a dielectric material, wherein the coaxial antennais arranged to couple microwave energy to/from tissue at the insertiontip, and the channel is formed within the inner conductor or in an outerportion of the outer conductor. The inner conductor may be a conductivelayer along an inside wall of the channel. Preferably, the innerconductor is a conductive layer (tube) that defines the channel.Preferably, the outer conductor comprises a conductive layer formed onthe outer surface of the elongate body. The outer conductor may comprisea conductive layer formed on the dielectric material and an annular orpart annular channel formed on that conductive layer. The coupledmicrowave energy may be selectable either to measure properties oftissue at the insertion tip or to ablate tissue at the tip.

In another aspect of the invention, there may be provided needle biopsyapparatus comprising a biopsy needle as described above and a microwavepower source arranged to deliver microwave frequency energy to thecoaxial antenna in the needle in order to measure and/or ablate tissueat the insertion tip of the needle. The apparatus may include a dynamicimpedance tuner arranged to adjust the impedance of the needle e.g. tomatch the impedance of the tissue at the insertion tip in order toensure even (uniform) energy delivery into the tissue. This aspect ofthe invention offers an advantage in that it enables uniform ablation ofthe channel through which the antenna is inserted to prevent theoccurrence of seeding. The ability to dynamically match into varioustissue structures prevents uneven ablation due to variations in matchingto various tissue types as the tip of the antenna moves through thevarious structures.

In other words, the needle antenna described in this specification cancouple microwave frequency energy into a co-axial structure for thepurpose of making tissue type/state measurements, and/or for performingcontrolled tissue ablation, and has a hollow tube center conductor toenable tissue biopsies to be performed before, after, or during thetissue ablation process. The structure disclosed in the currentinvention may, therefore, be considered as a tri-functional needleantenna. The frequency of choice used in the current invention, and themicrowave aspects of the design of the tri-functional antenna structuremakes it possible to measure information regarding the state of thebiological tissue at the same location (position) as where the tissuebiopsy is to be physically taken, i.e. at the distal tip.

In this specification, microwave frequency means a frequency range ofbetween 1 GHz to 100 GHz, preferably 5 GHz to 60 GHz. Higherfrequencies, e.g. up to 200 GHz may also be used. More preferably, thefrequency source used operates at a frequency of between 14 GHz and 15GHz, and, even more preferably, operates at a spot frequency of 14.5GHz.

It may also be desirable to use a dynamically adjustable tuning filter,for example, a waveguide cavity containing three tuning stubs with aspacing of a quarter of the guide wavelength at the frequency ofinterest, to create a conjugate match between the distal tip of theneedle antenna and the load presented by the biological tissuestructure. It should be understood that the tuning filter is positionedbetween the output from the power amplifier and the distal tip of theneedle antenna to enable the output impedance of the amplifier to bematched to the input impedance of the tuning filter, and the outputimpedance of the tuning filter to be matched to the impedance of thebiological tissue. This feature enables the needle antenna to be used toperform controlled ablation of a volume of cancerous tissue or toperform controlled ablation (or sealing) of the needle track (orchannel).

The ability of the needle antenna to convey information back to themeasurement system to allow dynamic impedance matching to be performedbetween the changing tissue impedance and the generator enables theenergy delivered into the various tissue structures that exist along thetrack between the site where the tissue biopsy (or the tumor ablation)takes place and the outside world to be automatically regulated toprovide uniform tissue ablation of healthy tissue structures en route,i.e. it may be desirable to ablate a channel of 4 mm diameter of healthytissue along the track (or channel) to prevent the seeding of cancerouscells. The ability of the needle antenna structure to allow for the modeof operation described above to be performed may be an additionalfeature of the current invention.

The invention may not be limited to using a single frequency source forperforming controlled ablation and making dielectric measurement. Aplurality of frequency sources may be used. For example, it may beadvantageous to use a lower microwave frequency, for example 1 GHz to 10GHz, for performing controlled ablation, and a higher microwavefrequency, for example, 20 GHz to 100 GHz, for performing dielectricmeasurements. The embodiments of the invention described below use asingle frequency source operating at 14.5 GHz, which has the advantageof producing a high energy density for controlled ablation of smalltumors and effective track (or channel) sealing, and a small enoughradiation distance to allow for dielectric measurements that arelocalized to the end of the distal tip to be performed. The advantage ofusing lower microwave frequencies for tumor ablation is that the largerpenetration depths associated with low frequency microwave energy may bebeneficial in terms of producing effective ablation of large tumors, andthe advantage of using higher microwave frequencies for dielectricmeasurement is that the small radiation distances associated with highfrequency microwave energy may be beneficial in terms of effectivelyperforming local tissue measurements that are unaffected by surroundingtissue structures.

A surgical location monitoring system and method disclosed in U.S. Pat.No. 9,566,123 may be adapted for the present invention. A computergenerally includes a processor for executing instructions and memory forstoring instructions and data, including interfaces to obtain andprocess imaging data. When a general-purpose computer has a series ofmachine encoded instructions stored in its memory, the computeroperating on such encoded instructions may become a specific type ofmachine, namely a computer particularly configured to perform theoperations embodied by the series of instructions. Some of theinstructions may be adapted to produce signals that control operation ofother machines and thus may operate through those control signals totransform materials far removed from the computer itself. Thesedescriptions and representations are the means used by those skilled inthe art of data processing arts to most effectively convey the substanceof their work to others skilled in the art.

An algorithm is generally, conceived to be a self-consistent sequence ofsteps leading to a desired result. These steps are those requiringphysical manipulations of physical quantities, observing and measuringscanned data representative of matter around the surgical site. Usually,though not necessarily, these quantities take the form of electrical ormagnetic pulses or signals capable of being stored, transferred,transformed, combined, compared, and otherwise manipulated. It provesconvenient at times, principally for reasons of common usage, to referto these signals as bits, values, symbols, characters, display data,terms, numbers, or the like as a reference to the physical items ormanifestations in which such signals are embodied or expressed tocapture the underlying data of an image. It should be borne in mind,however, that all of these and similar terms are to be associated withthe appropriate physical quantities and are merely used here asconvenient labels applied to these quantities.

Some algorithms may use data structures for both inputting informationand producing the desired result. Data structures greatly facilitatedata management by data processing systems, and are not accessibleexcept through sophisticated software systems. Data structures are notthe information content of a memory, rather they represent specificelectronic structural elements that impart or manifest a physicalorganization on the information stored in memory. More than mereabstraction, the data structures are specific electrical or magneticstructural elements in memory, which simultaneously represent complexdata accurately, often data modeling physical characteristics of relateditems, and provide increased efficiency in computer operation.

Further, the manipulations performed are often referred to in terms,such as comparing or adding, commonly associated with mental operationsperformed by a human operator. No such capability of a human operator isnecessary, or desirable in most cases, in any of the operationsdescribed herein that form part of the present invention; the operationsare machine operations. Useful machines for performing the operations ofthe present invention include general-purpose digital computers or othersimilar devices. In all cases the distinction between the methodoperations in operating a computer and the method of computation itselfshould be recognized. The present invention relates to a method andapparatus for operating a computer in processing electrical or other(e.g., mechanical, chemical) physical signals to generate other desiredphysical manifestations or signals. The computer operates on softwaremodules, which are collections of signals stored on a media thatrepresents a series of machine instructions that enable the computerprocessor to perform the machine instructions that implement thealgorithmic steps. Such machine instructions may be the actual computercode the processor interprets to implement the instructions, oralternatively may be a higher level coding of the instructions that isinterpreted to obtain the actual computer code. The software module mayalso include a hardware component, wherein some aspects of the algorithmare performed by the circuitry itself rather as a result of aninstruction.

The present invention also relates to an apparatus for performing theseoperations. This apparatus may be specifically constructed for therequired purposes or it may comprise a general-purpose computer asselectively activated or reconfigured by a computer program stored inthe computer. The algorithms presented herein are not inherently relatedto any particular computer or other apparatus unless explicitlyindicated as requiring particular hardware. In some cases, the computerprograms may communicate or relate to other programs or equipmentthrough signals configured to particular protocols, which may or may notrequire specific hardware or programming to interact. In particular,various general-purpose machines may be used with programs written inaccordance with the teachings herein, or it may prove more convenient toconstruct more specialized apparatus to perform the required methodsteps. The required structure for a variety of these machines willappear from the description below.

The present invention may deal with “object-oriented” software, andparticularly with an “object-oriented” operating system. The“object-oriented” software is organized into “objects”, each comprisinga block of computer instructions describing various procedures(“methods”) to be performed in response to “messages” sent to the objector “events” which occur with the object. Such operations include, forexample, the manipulation of variables, the activation of an object byan external event, and the transmission of one or more messages to otherobjects. Often, but not necessarily, a physical object has acorresponding software object that may collect and transmit observeddata from the physical device to the software system. Such observed datamay be accessed from the physical object and/or the software objectmerely as an item of convenience; therefore where “actual data” is usedin the following description, such “actual data” may be from theinstrument itself or from the corresponding software object or module.

Messages are sent and received between objects having certain functionsand knowledge to carry out processes. Messages are generated in responseto user instructions, for example, by a user activating an icon with a“mouse” pointer generating an event. Also, messages may be generated byan object in response to the receipt of a message. When one of theobjects receives a message, the object carries out an operation (amessage procedure) corresponding to the message and, if necessary,returns a result of the operation. Each object has a region whereinternal states (instance variables) of the object itself are stored andwhere the other objects are not allowed to access. One feature of theobject-oriented system is inheritance. For example, an object fordrawing a “circle” on a display may inherit functions and knowledge fromanother object for drawing a “shape” on a display.

A programmer “programs” in an object-oriented programming language bywriting individual blocks of code each of which creates an object bydefining its methods. A collection of such objects adapted tocommunicate with one another by means of messages comprises anobject-oriented program. Object-oriented computer programmingfacilitates the modeling of interactive systems in that each componentof the system may be modeled with an object, the behavior of eachcomponent being simulated by the methods of its corresponding object,and the interactions between components being simulated by messagestransmitted between objects.

An operator may stimulate a collection of interrelated objectscomprising an object-oriented program by sending a message to one of theobjects. The receipt of the message may cause the object to respond bycarrying out predetermined functions, which may include sendingadditional messages to one or more other objects. The other objects mayin turn carry out additional functions in response to the messages theyreceive, including sending still more messages. In this manner,sequences of message and response may continue indefinitely or may cometo an end when all messages have been responded to and no new messagesare being sent. When modeling systems utilizing an object-orientedlanguage, a programmer need only think in terms of how each component ofa modeled system responds to a stimulus and not in terms of the sequenceof operations to be performed in response to some stimulus. Suchsequence of operations naturally flows out of the interactions betweenthe objects in response to the stimulus and need not be preordained bythe programmer.

Although object-oriented programming makes simulation of systems ofinterrelated components more intuitive, the operation of anobject-oriented program is often difficult to understand because thesequence of operations carried out by an object-oriented program isusually not immediately apparent from a software listing as in the casefor sequentially organized programs. Nor is it easy to determine how anobject-oriented program works through observation of the readilyapparent manifestations of its operation. Most of the operations carriedout by a computer in response to a program are “invisible” to anobserver since only a relatively few steps in a program typicallyproduce an observable computer output.

In the following description, several terms that are used frequentlyhave specialized meanings in the present context. The term “object”relates to a set of computer instructions and associated data, which maybe activated directly or indirectly by the user. The terms “windowingenvironment”, “running in windows”, and “object oriented operatingsystem” are used to denote a computer user interface in whichinformation is manipulated and displayed on a video display such aswithin bounded regions on a raster scanned video display. The terms“network”, “local area network”, “LAN”, “wide area network”, or “WAN”mean two or more computers that are connected in such a manner thatmessages may be transmitted between the computers. In such computernetworks, typically one or more computers operate as a “server”, acomputer with large storage devices such as hard disk drives andcommunication hardware to operate peripheral devices such as printers ormodems. Other computers, termed “workstations”, provide a user interfaceso that users of computer networks may access the network resources,such as shared data files, common peripheral devices, andinter-workstation communication. Users activate computer programs ornetwork resources to create “processes” which include both the generaloperation of the computer program along with specific operatingcharacteristics determined by input variables and its environment.Similar to a process is an agent (sometimes called an intelligentagent), which is a process that gathers information or performs someother service without user intervention and on some regular schedule.Typically, an agent, using parameters typically provided by the user,searches locations either on the host machine or at some other point ona network, gathers the information relevant to the purpose of the agent,and presents it to the user on a periodic basis.

The term “desktop” means a specific user interface which presents a menuor display of objects with associated settings for the user associatedwith the desktop. When the desktop accesses a network resource, whichtypically requires an application program to execute on the remoteserver, the desktop calls an Application Program Interface, or “API”, toallow the user to provide commands to the network resource and observeany output. The term “Browser” refers to a program which is notnecessarily apparent to the user, but which is responsible fortransmitting messages between the desktop and the network server and fordisplaying and interacting with the network user. Browsers are designedto utilize a communications protocol for transmission of text andgraphic information over a worldwide network of computers, namely the“World Wide Web” or simply the “Web”. Examples of Browsers compatiblewith the present invention include the Internet Explorer program sold byMicrosoft Corporation (Internet Explorer is a trademark of MicrosoftCorporation), the Opera Browser program created by Opera Software ASA,or the Firefox browser program distributed by the Mozilla Foundation(Firefox is a registered trademark of the Mozilla Foundation). Althoughthe following description details such operations in terms of a graphicuser interface of a Browser, the present invention may be practiced withtext based interfaces, or even with voice or visually activatedinterfaces, that have many of the functions of a graphic based Browser.

Browsers display information, which is formatted in a StandardGeneralized Markup Language (“SGML”) or a HyperText Markup Language(“HTML”), both being scripting languages, which embed non-visual codesin a text document through the use of special ASCII text codes. Files inthese formats may be easily transmitted across computer networks,including global information networks like the Internet, and allow theBrowsers to display text, images, and play audio and video recordings.The Web utilizes these data file formats to conjunction with itscommunication protocol to transmit such information between servers andworkstations. Browsers may also be programmed to display informationprovided in an eXtensible Markup Language (“XML”) file, with XML filesbeing capable of use with several Document Type Definitions (“DTD”) andthus more general in nature than SGML or HTML. The XML file may beanalogized to an object, as the data and the stylesheet formatting areseparately contained (formatting may be thought of as methods ofdisplaying information, thus an XML file has data and an associatedmethod).

The terms “personal digital assistant” or “PDA”, as defined above, meansany handheld, mobile device that combines computing, telephone, fax,e-mail and networking features. The terms “wireless wide area network”or “WWAN” mean a wireless network that serves as the medium for thetransmission of data between a handheld device and a computer. The term“synchronization” means the exchanging of information between a firstdevice, e.g. a handheld device, and a second device, e.g. a desktopcomputer, either via wires or wirelessly. Synchronization ensures thatthe data on both devices are identical (at least at the time ofsynchronization).

In wireless wide area networks, communication primarily occurs throughthe transmission of radio signals over analog, digital cellular, orpersonal communications service (“PCS”) networks. Signals may also betransmitted through microwaves and other electromagnetic waves. At thepresent time, most wireless data communication takes place acrosscellular systems using second generation technology such ascode-division multiple access (“CDMA”), time division multiple access(“TDMA”), the Global System for Mobile Communications (“GSM”), ThirdGeneration (wideband or “3G”), Fourth Generation (broadband or “4G”),personal digital cellular (“PDC”), or through packet-data technologyover analog systems such as cellular digital packet data (“CDPD”) usedon the Advance Mobile Phone Service (“AMPS”).

The terms “wireless application protocol” or “WAP” mean a universalspecification to facilitate the delivery and presentation of web-baseddata on handheld and mobile devices with small user interfaces. “MobileSoftware” refers to the software operating system, which allows forapplication programs to be implemented on a mobile device such as amobile telephone or PDA. Examples of Mobile Software are Java and JavaME (Java and JavaME are trademarks of Sun Microsystems, Inc. of SantaClara, Calif.), BREW (BREW is a registered trademark of QualcommIncorporated of San Diego, Calif.), Windows Mobile (Windows is aregistered trademark of Microsoft Corporation of Redmond, Wash.), PalmOS (Palm is a registered trademark of Palm, Inc. of Sunnyvale, Calif.),Symbian OS (Symbian is a registered trademark of Symbian SoftwareLimited Corporation of London, United Kingdom), ANDROID OS (ANDROID is aregistered trademark of Google, Inc. of Mountain View, Calif.), andiPhone OS (iPhone is a registered trademark of Apple, Inc. of Cupertino,Calif.), and Windows Phone 7. “Mobile Apps” refers to software programswritten for execution with Mobile Software.

The terms “scan,” “fiducial reference”, “fiducial location”, “marker,”“tracker” and “image information” have particular meanings in thepresent disclosure. For purposes of the present disclosure, “scan” orderivatives thereof refer to x-ray, magnetic resonance imaging (MRI),computerized tomography (CT), sonography, cone beam computerizedtomography (CBCT), or any system that produces a quantitative spatialrepresentation of a patient. The term “fiducial reference” or simply“fiducial” refers to an object or reference on the image of a scan thatis uniquely identifiable as a fixed recognizable point. In the presentspecification the term “fiducial location” refers to a useful locationto which a fiducial reference is attached. A “fiducial location” willtypically be proximate a surgical site. The term “marker” or “trackingmarker” refers to an object or reference that may be perceived by asensor proximate to the location of the surgical or dental procedure,where the sensor may be an optical sensor, a radio frequency identifier(RFID), a sonic motion detector, an ultra-violet or infrared sensor. Theterm “tracker” refers to a device or system of devices able to determinethe location of the markers and their orientation and movementcontinually in ‘real time’ during a procedure. As an example of apossible implementation, if the markers are composed of printed targetsthen the tracker may include a stereo camera pair. The tracker mayinclude a non-stereo optical camera or a stereo camera pair, which mayoperate in the visible or infrared region of the spectrum. The term“image information” is used in the present specification to describeinformation obtained by the tracker, whether optical or otherwise, aboutone or more tracking markers and usable for determining the location ofthe markers and their orientation and movement continually in ‘realtime’ during a procedure.

Data communication between a central processor and system memory, whichmay include read-only memory (ROM) or flash memory, and random accessmemory (RAM). RAM is generally the main memory into which operatingsystem and application programs are loaded. ROM or flash memory maycontain, among other software code, Basic Input-Output system (BIOS),which controls basic hardware operation such as interaction withperipheral components. Applications resident with computer system aregenerally stored on and accessed via computer readable media, such ashard disk drives, optical drives, a floppy disk unit, or other storagemedium. Additionally, applications may be in the form of electronicsignals modulated in accordance with the application and datacommunication technology when accessed via a network modem or interfaceor other telecommunications equipment (not shown).

A storage interface, as with other storage interfaces of computersystem, may connect to standard computer readable media for storageand/or retrieval of information, such as a fixed disk drive. The fixeddisk drive may be part of a computer system or may be separate andaccessed through other interface systems. A modem may provide directconnection to remote servers via telephone link or the Internet via anInternet service provider (ISP). A network interface may provide directconnection to remote servers via direct network link to the Internet viaa POP (point of presence). A network interface may provide suchconnection using wireless techniques, including digital cellulartelephone connection, Cellular Digital Packet Data (CDPD) connection,digital satellite data connection or the like.

Many other devices or subsystems (not shown) may be connected in asimilar manner (e.g., document scanners, digital cameras and so on),including hardware components, which alternatively may be incommunication with associated computational resources through local,wide-area, or wireless networks or communications systems. The hardwarecomponents may be directly connected or remotely connected withcomputing resources. Software source and/or object codes to implementthe present disclosure may be stored in computer-readable storage mediasuch as one or more of a system memory, fixed disk, optical disk, orfloppy disk. The operating system provided on computer system 210 may bea variety or version of either MS-DOS® (MS-DOS is a registered trademarkof Microsoft Corporation of Redmond, Wash.), WINDOWS® (WINDOWS is aregistered trademark of Microsoft Corporation of Redmond, Wash.), OS/2®(OS/2 is a registered trademark of International Business MachinesCorporation of Armonk, N.Y.), UNIX® (UNIX is a registered trademark ofX/Open Company Limited of Reading, United Kingdom), Linux® (Linux is aregistered trademark of Linus Torvalds of Portland, Oreg.), or otherknown or developed operating system.

Moreover, regarding the signals described herein, those skilled in theart recognize that a signal may be directly transmitted from a firstblock to a second block, or a signal may be modified (e.g., amplified,attenuated, delayed, latched, buffered, inverted, filtered, or otherwisemodified) between blocks. Although the signals of the above-describedembodiments are characterized as transmitted from one block to the next,other embodiments of the present disclosure may include modified signalsin place of such directly transmitted signals as long as theinformational and/or functional aspect of the signal is transmittedbetween blocks. To some extent, a signal input at a second block may beconceptualized as a second signal derived from a first signal outputfrom a first block due to physical limitations of the circuitry involved(e.g., there will inevitably be some attenuation and delay). Therefore,as used herein, a second signal derived from a first signal includes thefirst signal or any modifications to the first signal, whether due tocircuit limitations or due to passage through other circuit elementswhich do not change the informational and/or final functional aspect ofthe first signal.

The present invention also contemplates microdot projector mapping oflumen based organs via the endoscope of the present invention. Forexample, a probe that had a microdot projector may fit through a channelor attached the tip of a camera.

US Patent Publication 20160296692 discloses a system for injecting fluidto a patient. The system provides manual or automatic verification andidentification of the fluid to be injected, prior to, during or afterinjection. The system includes: a fluid having at least one activecompound and at least one tracer compound; an injector configured todeliver the fluid to the patient through a fluid path set; at least onesensor coupled to at least one of the syringe, the injector, or thepatient, configured to measure at least one property of the tracer inthe fluid, and a feedback path to adjust at least one injectionparameter of the injector based on at least one measurement from the atleast one sensor.

In certain embodiments, the at least one sensor may be coupled to atissue section of a patient, such as, for example a dermal tissuesection of a patient. In other embodiments, the at least one sensor maybe associated with an internal tissue section of the patient, such aswhere the at least one sensor is on an endoscope, catheter or othermedical device inserted within the patient. According to variousembodiments, the at least one sensor may be configured to measure invivo at least one property of the injection fluid such as, for example aconcentration of the tracer compound at a site within the patient nearthe tissue section, a location of the tracer compound within a vascularsystem of the patient near the tissue section, an extravasation of thetracer compound outside of the vascular system of the patient near thetissue section, or combinations of any thereof.

Microdots and micro-labels may be printed or laser-etched to the surfaceof the syringe barrel for proper identification. Microdots aremicroscopic particles, which are typically about one thousand microns insize and include alpha-numeric sequences. The microdots may be printedor laser-etched to a surface to form a barcode-like structure. Varioussensors may be used to extract data about the barcode-like structure.Additionally, microdots can include voids within molded dots thatreflect various wavelengths of light in readily identifiable patterns.The injector may include a light source at a specific wavelength andsensors configured to measure the predefined reflection. The type ofreflection could be used to provide additional information about thesyringe or fluid solution. The information may be used foridentification and authentication purposes.

US Patent Publication 20050221279 discloses a method for creatingchemical sensors using contact-based microdispensing technology. Contactbased rigid pin tool technology is utilized to print one or moreindicator chemistries on an optical array or a disposable sheathconfigured on such arrays. Each indicator chemistry containspredetermined material, such as, light energy absorbing dye(s),optically responsive particles, etc., whose optical characteristicschange in response to the target ligand or analyte. By spectrallymonitoring such changes using fluorescence and/or absorptionspectroscopy, detection and/or quantitation of the target ligand oranalyte can be obtained.

For in vivo applications it is desirable to have the sensor portioncontained in a probe capable of accessing the desired sample. Thesensor, for example, can be incorporated in a mechanical periodontalprobe for sampling the gingival crevicular fluid and saliva; a needlefor accessing tissue; a catheter, endoscope, or guidewire for monitoringblood constituents; a cone penetrometer for making soil gasmeasurements; or a down well sampler for groundwater monitoring, amongothers. A fiber optic bundle is a natural choice for these applications,since fibers can guide light long distances with minimal loss ofintensity and are very compact. An optical array, such as a standardfiber imaging bundle, may contain 1000's of individually clad opticalfibers in a small diameter bundle (<500 .mu.m). Since each microdotoverlays at least one imaging fiber the orientation (i.e. rotation) ofthe bundle tip relative to the rigid tool printing element becomes lessimportant, making sensor manufacture much easier and allowing many moreindicator microdots to be placed in a given area. The microdots caneither be printed directly on the distal end of the fiber bundle orprinted on the tip of a disposable sleeve (e.g. plastic) that can beslipped over the end of the imaging fiber bundle.

A user can create and visualize a customized pattern of microdots simplyby using a drag-and-drop tool from a palette of up to conceivably 1596color-coded chemistries. Each chemistry is color-coded, as specified bythe user, within the software and mapped to one well in a standard wellplate. The user can save this pattern to a file, or load a previouslysaved pattern to the pattern editor. After placing dots on a patterneditor template, individual dots can be selected and the position finelytuned by adjusting coordinates. The order in which microdots are printedis determined by the placement order in the pattern editor. Inmulti-chemistry printing, all microdots of like chemistries are printedin sequence.

An automated routine executes a single printing cycle for each indicatorchemistry specified in a desired custom pattern. The printing cycleincludes chemistry pickup from a specified well in a well plate,conditioning the sample delivery of the rigid tool by printing aspecified number of microdots on a predetermined blotting substrate(e.g., a glass slide), printing the desired microdot configuration on apredetermined optical array, such as, for example, optical fiberbundles, and cleaning the rigid pin printing tool according to a userspecified wash cycle before the next chemistry pickup. In a settingsmenu, a user can specify which wells are used for sample pickup, thestages in a wash cycle, the conditioning procedure, the descent speed ofthe rigid tool during printing, and the amount of time the tool rests onthe printing surface. It is possible to pause the automated routine,make modifications to the pattern or wash cycle, realign the rigid tooland optical array, or manually position the rigid tool before resumingthe routine. Spectroscopic measurements can be made using, for example,an imaging spectrometer.

Microdots of the present invention are often micron sized (e.g., lessthan about 500 microns) but can be nano-sized particles (e.g., about 100nanometers) of polymer spots that can, but not necessarily are requiredto, contain an indicator as disclosed herein. Such microdots can also bearranged to include additional layers (i.e., one or more layers) ofeither a polymer membrane (e.g., a hydrophobic membrane applied to apolymerized microdot that includes an indicator immobilized in ahydrophilic membrane) and/or an indicator immobilized in a polymer(i.e., an indicator chemistry) applied to a polymerized spot. Such anexample embodiment in the former case can be a sensor utilized as, forexample, a gas sensor. A latter example can include an enzymeimmobilized in a membrane with an accompanying indicator in a membrane.

Any of the endoscopic devices and/or elements thereof described hereinmay be used in conjunction with a system. Endoscopic systems may includemultiple elements as outlined herein.

All references cited in the present application are incorporated intheir entirety herein by reference to the extent not inconsistentherewith.

It will be seen that the advantages set forth above, and those madeapparent from the foregoing description, are efficiently attained andsince certain changes may be made in the above construction withoutdeparting from the scope of the invention, it is intended that allmatters contained in the foregoing description or shown in theaccompanying drawings shall be interpreted as illustrative and not in alimiting sense.

Having thus described in detail preferred embodiments of the presentinvention, it is to be understood that the invention defined by theabove paragraphs is not to be limited to particular details set forth inthe above description as many apparent variations thereof are possiblewithout departing from the spirit or scope of the present invention.

It is also to be understood that the following claims are intended tocover all of the generic and specific features of the invention hereindescribed, and all statements of the scope of the invention which, as amatter of language, might be said to fall therebetween. Now that theinvention has been described.

The present invention will be further illustrated in the followingExamples which are given for illustration purposes only and are notintended to limit the invention in any way.

Example 1—Materials and Methods

Subjects ages 8-17 years of age between March 2014 and January 2015 witha defined diagnosis of EoE and who had undergone at least one prior EGDunder anesthesia were recruited from the outpatient clinic at Children'sHospital Colorado (CHCO). At the time of the scheduled clinicallyindicated follow up appointment, subjects were approached if theirprimary GI provider felt a follow-up esophagoscopy was needed toevaluate their clinical response to therapy. Subjects were queried ifthey would be interested in having an unsedated TNE with moviedistraction performed instead of a sedated EGD. If so, informed consentwas obtained and demographic data collected.

Subjects were instructed to not eat or drink for 2 hours prior to theTNE. In a standard clinic room, subjects were asked to sit in a chairdesigned for outpatient laryngoscopic procedures. Two to six sprays of4% aerosolized lidocaine were applied to the nares to achieve topicalanesthesia. Subject distraction was accomplished using either HMZ-T3 W3D movie goggles (Sony Corporation, Tokyo, Japan) or Cinemizer Goggles(Carl Zeiss AG, Oberkochen, Germany) dependent on facial size tofacilitate viewing an immersive movie or television program of theirchoice. Parents remained in the room for the duration of the study. Forstudy design purposes and patient comfort one of two designatedpulmonologists (ED, RD) or a single otolaryngologist (JP) performedtransnasal laryngoscopy using an Olympus BFXP160F 2.8 mm bronchoscope(1.2 mm biopsy channel) in 11/21 subjects and 10/21 subjects using a 4mm BPMP160F (2 mm biopsy channel) ending with the endoscope in theproximal esophagus. The gastroenterologist (JF) performed esophagoscopyand biopsy collection (3 from proximal and 3 from distal esophagus).Visual confirmation of the adequacy of the biopsy specimens wasperformed before withdrawing scope. Adverse events, subject symptoms,duration of TNE in 5 minute intervals up to 15 minutes were collected.After the procedure, families were asked to answer the mGHAA-9 (modifiedGroup Health Association of America) endoscopy satisfactionquestionnaire and discharged home.

Subjects were called the evening of the procedure and >72 hours later toevaluate for any adverse events. A minimum of two weeks but not greaterthan 10 weeks after TNE, the subjects and parents were asked to answeran electronic qualitative survey regarding their experience with TNE.

A single pediatric pathologist (KC) evaluated biopsy specimens to assessfor size of the sample and inflammatory findings including eosinophilenumeration. To assure adequate high power field (hpf) analysis, thetotal epithelial surface area used to count eosinophils was analyzedusing graphical software and analysis (cellSens Standard, 2013, OlympusAmerica, USA). This was accomplished by comparing the subject'savailable previous esophageal biopsies using a standard 2.8 mm biopsyforceps to the 1.2 or 2 mm biopsy forceps specimens that were collectedduring TNE.

Charges from TNEs and subjects' previous isolated sedated EGD werecollected to compare the cost of the two procedures. Subjects whounderwent combined procedures that may have prolonged sedation such aspH probes, pH impedance probes, colonoscopy, or flexible sigmoidoscopyat their previous endoscopy were excluded from this calculation (n=12).University of Colorado Institutional Review Board (COMIRB-13-2721)approved all study procedures.

Data was recorded into a Red-Cap Secure Database. It is reported asqualitative measure as noted with average, mean, and standard deviation(SD). Surface area analysis to assure adequate specimen size wasperformed using student's paired, non-parametric, t-test. Chargeanalysis was performed using unpaired t-test.

Example 2—Evaluation of the Pediatric Nasal Endoscope

Of 22 subjects referred for endoscopy, 22 were contacted and 21 subjects(95.5%) enrolled in this study. One female subject chose not toparticipate because of “sensory issues.” Clinical features of these 21subjects are shown in Table 1. The average age was 13.04 yrs (+\−2.7 yrsSD, range from 8-17 years). Subject numbers 1, and 13-21 underwent TNEusing the 4 mm endoscope and were aged ranging from 8-16 years. Subjectnumbers 2-12 underwent TNE using the 2.8 mm endoscope and were agedranging from 10-17 years. The average number of endoscopies previouslyperformed on the subject cohort was 2.19 (SD+/−1.12). All subjectstolerated TNE with no significant adverse events. Duration of TNEprocedures decreased as the endoscopists (JF, ED, JP, RD) became moreexperienced with TNE. (Table 2). The youngest child was 8 years old andwas able to tolerate the 4 mm endoscope without difficulty. Symptomsassociated with the TNE included gagging and sore throat (Table 3). Noadverse event was associated with any emergency department evaluation orunintended evaluation or treatment. One subject had a panic attack priorto the procedure but was still able to complete the TNE without anyadditional medication. She had a previous history of an anxietydisorder.

Post-procedure assessment revealed a high degree of satisfaction andcomfort with the TNE immediately after and at subsequent survey. mGHAA-9satisfaction instrument average score was 43.19+/−2.6 n=21; maximum 45.A high percentage of subjects reported satisfaction with TNE, childsubjects (81%) and parents (90.5%). This is as compared to 81% ofcombined parent/child subjects satisfied with their previous sedated EGDwhen asked about it at time of TNE survey. Subjects expressed greaterconcerns for EGD than TNE on qualitative instrument (61.9% vs. 28.6%respectively). The majority of children (76.2%) would repeat TNE and100% of parental subjects were willing to have their child undergo theprocedure again. More than half of child subjects 52.4% preferred TNE,with 4 subjects not preferring either TNE or sedated EGD, while 85.7% ofparental subjects preferred TNE for their child. (Table 4). Reasons forparental preference of TNE included: no anesthesia (61.9%) fasterprocedure and recovery (52.3%), parental presence during the procedure(28.5%), and lower cost (19%).

Visual TNE findings revealed 11 subjects with normal esophagoscopy, 9with furrowing and one with furrowing and exudates. Visual findingscorrelated to the appropriate histologic findings in 85.7% of subjects.In those subjects where visual and histological findings did notcorrelate, 2 subjects with visual furrowing had normal biopsies, and onewith normal appearing mucosa showed histological evidence ofeosinophilia <15 eos hpf. (Image 1, Table 5)

Biopsy specimens revealed 12 normal biopsies, 4 with less than 15eosinophils per hpf, and 5 with greater than 15 eosinophils per hpf.(Table 5, Image 1) No significant difference was identified whencomparing total epithelial surface area of TNE biopsies to the biopsysurface area of the matched subject's previous EGD. (Table 5) Onesubject that was initially evaluated at an outside institution did nothave his previous biopsies available for analysis. Total epithelialsurface area of mucosal biopsies samples from TNE forceps compared tothose obtained with standard endoscopic forceps was not statisticallydifferent. (0.33 mm²+/−0.09 vs. 0.38 mm²+/−0.14 mm; p=0.308; n=11; TNE1.2 mm forceps vs EGD 2.8 mm forceps+/−SD 0.50 mm2+/−0.15 vs. 0.52mm2+/−0.19; p=0.496, n=9; TNE 2 mm forceps vs EGD 2.8 mm forceps+/−SD).Although there appears to be a surface area difference between the two2.8 mm control groups (0.38 mm2 and 0.52 mm2), sub-analysis revealed nosignificant difference was present using unpaired, non-parametrict-test. (p>0.05)

Of the 21 subjects who underwent TNE, 11 had charge data that wascomparable and available for analysis. Charges for TNE were calculatedto be 60.1% less than sedated EGD with biopsies, including anesthesia,pathology, facility fees, and physician fees.

TABLE 1 Demographics Age Average Number of Gender (n) Ethnicity (years)Previous Endoscopies (n) Male = 13 Caucasian = 19 (1 13.04 2.26 (SD +/−1.15) Female = 9 (1 not enrolled) (SD +/− not enrolled) Native American= 1 2.7) Hispanic = 2

TABLE 2 Duration of TNE Age Average Number of Gender (n) Ethnicity(years) Previous Endoscopies (n) Male = 13 Caucasian = 19 (1 not 13.042.26 (SD +/− 1.15) Female = 9 (1 enrolled) (SD +/− not enrolled) NativeAmerican = 1 2.7) Hispanic = 2

TABLE 3 Adverse Events Self Reported Symptom Total Number of SubjectsReporting Symptom Nausea 4 Choking/Gagging 12 Sore Throat 10 Vomiting 2Chest Pain 2 Abdominal Pain 1 Other 4 (2 reporting nose discomfort; 2reporting slightly sore throat) No Significant Symptoms 7

TABLE 4 Satisfaction with the Procedure Instrument/Question InstrumentScore mGHAA-9 Score (Max 45 Points) 43.19 (SD +/− 2.6) QualitativeSatisfaction Instrument Total Subject of 21 total (n) Child:Satisfaction with TNE 17 (81%) Parent: Satisfaction with TNE 19 (90.5%)Parent/Child Satisfied with 17 (81%) Sedated EGD Parent/Child Concernedwith 13 (61.9%) Sedated EGD Child: Willing to Repeat TNE 16 (76.2%)Parent: Willing to Repeat TNE 21 (100%) Child: Prefer to Repeat TNE 11(52.4%)-4 prefer neither EGD or TNE Parent: Prefer to Repeat TNE 18(85.7%)-1 prefer neither EGD or TNE Parent: Qualitative Advantages13/21-No anesthesia of TNE 11/21-Faster procedure and recovery6/21-Parental presence in the procedure room 4/21-Lower cost

TABLE 5 TNE Findings TNE Findings Total Specimens (n) Visually Normal 11Slight Furrowing 2 Furrowing 8 (1 with exudates) Normal BiopsyAbnormality 12 Eosinophils > 15 hpf 5 Eosinophils > 15 hpf 4 AverageEpitheleal Biopsy Forceps Sample Size Surface Area (mm²) P-value EGD 2.8mm* n = 11 0.38 (SD 0.14) P = 0.308 biopsy forceps TNE 1.2 mm 0.33 (SD0.09) biopsy forceps EGD 2.8 mm* n = 9  0.52 (SD 0.19) P = 0.496 biopsyforceps TNE 2.0 mm 0.50 (SD 0.15) biopsy forceps * * *

Having thus described in detail preferred embodiments of the presentinvention, it is to be understood that the invention defined by theabove paragraphs is not to be limited to particular details set forth inthe above description as many apparent variations thereof are possiblewithout departing from the spirit or scope of the present invention.

What is claimed is:
 1. A device comprising: a control elementcomprising: one or more ports; one or more interface elements; and oneor more indicators; an elongated element coupled to the control elementand having a cross-sectional outer diameter of less than about 3.5millimeter, comprising: a non-collapsible conduit having a diameter in arange between about 1.0 to about 2.5 millimeter in diameter; a distalelement coupled to the elongated element comprising: an illuminationelement; and an optical element for transmitting data encoding imagesand/or video to an external display.
 2. The device of claim 1 whereinthe diameter of the non-collapsible conduit is in a range between about1.3 to about 2.2 millimeter.
 3. The device of claim 1 wherein thecontrol element is optionally removable.
 4. The device of claim 1wherein at least one of the interface elements of the control element isa four-way or greater distal element control mechanism.
 5. The device ofclaim 1 wherein the diameter of the non-collapsible conduit is in arange between about 1.3 to about 2.2 millimeter.
 6. The device of claim1 further comprising a voice activated and voice dictation reportingsystem.
 7. The device of claim 1 wherein the display comprises at leastone of a video monitor, wearable electronics, and video goggles.
 8. Thedevice of claim 1 wherein the optical element is configured to transmitdata using at least one of a wired and a wireless transmission.
 9. Thedevice of claim 1 wherein the optical element has a field of view of atleast eighty-five degrees and a depth of view of greater than 5 mm. 10.The device of claim 1 wherein the optical element has a field of view ofat least eighty-five degrees and a depth of view of greater than 100 mm.11. The device of claim 1 further comprising a sound interface in thecontrol element coupled to a computer system to allow dictation of ausers voice or voice activation of its features.
 12. The device of claim1 further comprising an distance and location sensor that interfaces acomputer system to note location and distance of scope from insertionpoint of scope.
 13. The device of claim 12 wherein the distance andlocation sensor interacts with at least one of a sensor or markerpositioned on a patient during use.
 14. The device of claim 1 furthercomprising a sensor that measures the luminal diameter and surfacefeatures of the body cavity the scope is visualizing
 15. A systemcomprising: a removable control element comprising: one or more ports;one or more interface elements; and one or more indicators; an elongatedelement coupled to the control element having a cross-sectional outerdiameter of less than four millimeter, comprising: a channel having adiameter of in a range between 1.3 mm to 2.2 mm; a distal elementcomprising: an illumination element; an optical element; and a computercontrol unit comprising: one or more device drivers; a computer; and adisplay element.
 16. The system of claim 15 further comprising an audioelement.
 17. The system of claim 16 further comprising a sensor array.18. The system of claim 15 further comprising an illumination source.19. The system of claim 17, where at least one interface element isconfigured to send data from at least one of the optical element, theaudio element and the sensor array to a computer.
 20. A systemcomprising: an elongated element having an outer diameter of less thanfour millimeter, comprising: a channel having a diameter of at least 1.3mm and not greater than 2.2 mm; and a conduit that can be used as afeeding tube; a distal element comprising: an illumination element; anoptical element; and a computer control unit comprising: a computer; anda display element.